HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER

Description of Event or Problem

IT WAS REPORTED THAT THE CONTROLLER DID NOT RECOGNIZE THE NEW FULLY CHARGE BATTERY. THE CONTROLLER ALARMED. THE ALARM STARTED ON THE OTHER BATTERY WHICH HAD ONE BAR OF CHARGE. THE PATIENT CHANGED THE NEW BATTERY TO THE OLD BATTERY AND THE CONTROLLER STILL DID NOT RECOGNIZE THAT BATTERY EITHER. THE CONTROLLER FINALLY RECOGNIZED THE ALMOST DEPLETED BATTERY. IT WAS UNSURE IF IT WAS THE BATTERY OR THE CONTROLLER PORT THAT WAS FAULTY. IT WAS ALSO STATED THAT THE PATIENT WAS UNWILLING TO TRAVEL TWO HOURS TO COME VISIT THE OUTPATIENT CLINIC, THEREFORE NO LOGFILES WERE AVAILABLE AS YET. THE PATIENT WAS RECENTLY TAKEN OFF THE HEART TRANSPLANT WAITING LIST, AND THIS WAS VERY STRESSFUL AND THE PATIENT HAS NOW LOST ALL HIS HOPE AND NOT REALLY KEEN ON CONTINUING LIVING. THE PATIENT HAS A SCHEDULE CHECK UP VISIT AT THE HOSPITAL IN (B)(6) 2022, AND WAS ASKED TO VISIT THE OUTPATIENT CLINIC NEXT WEEK BUT THE PATIENT REFUSED. THE PATIENT WAS INFORMED BY THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR TO CHECK THE PINS AND RESPONSE BACK TO VAD COORDINATOR IMMEDIATELY IF THERE WAS ANYTHING WRONG. IT WAS MENTION THAT IT IS UNLIKELY THAT THE PATIENT WILL PROVIDE PICTURES, BUT THE PATIENT PROMISED TO CALL IF THIS OCCURRED AGAIN. THE CONTROLLER AND THE BATTERIES REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / MODEL #: UNK / CATALOG #: UNK/ EXPIRATION DATE: UNK / SERIAL #: UNKNOWN UDI #: (B)(4) / DEVICE AVAILABLE FOR EVALUATION: NO / MFG DATE: UNK / LABELED FOR SINGLE USE: NO / (B)(4). ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / MODEL #: UNK / CATALOG #: UNK/ EXPIRATION DATE: UNK / SERIAL #: UNKNOWN UDI #: (B)(4) / DEVICE AVAILABLE FOR EVALUATION: NO / MFG DATE: UNK / LABELED FOR SINGLE USE: NO / (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

IT WAS FURTHER REPORTED THAT THE CONTROLLER AND BATTERIES WERE SUSPECTED TO HAVE BENT PINS.

Additional Manufacturer Narrative

A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. NEWLY RECEIVED INFORMATION INDICATES THAT THE CONTROLLER A ND BATTERIES WERE SUSPECTED TO HAVE BENT PINS. ADDITIONAL PRODUCTS: UNKNOWN BATTERY H6: IMG CODE(S): G0403401 H6: FDA DEVICE CODE(S): A040609 UNKNOWN BATTERY H6: IMG CODE(S): G0403401 H6: FDA DEVICE CODE(S): A040609 INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative

A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR CORRECTION. H10 ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE CONTROLLER AND TWO BATTERIES SERIAL NUMBERS, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE UPDATED AND A SUPPLEMENTAL REPORT WILL BE SENT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative

A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: ONE CONTROLLER WITH AN UNKNOWN SERIAL NUMBER AND TWO BATTERIES WITH AN UNKNOWN SERIAL NUMBERS WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS WAS NOT PERFORMED SINCE LOG FILES WERE NOT AVAILABLE FOR ANALYSIS. AS A RESULT, THE REPORTED EVENT COULD NOT BE CONFIRMED. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; A POSSIBLE ROOT CAUSE OF THE INABILITY OF THE CONTROLLER TO RECOGNIZE THE BATTERIES MAY BE ATTRIBUTED, BUT NOT LIMITED, TO A FAULTY INTERNAL COMPONENT AND/OR POOR MECHANICAL CONNECTION. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; POSSIBLE ROOT CAUSES INVOLVING A BATTERY NOT BEING RECOGNIZED BY THE CONTROLLER CAN BE ATTRIBUTED, BUT NOT LIMITED, TO AN INTERNAL BATTERY COMMUNICATION ERROR, A FAULTY INTEGRATED CIRCUIT, AN IMPROPER WELD, AND/OR A SOLDERING DEFECT. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; A POSSIBLE ROOT CAUSE OF THE REPORTED BENT PINS AND ALARM EVENT CAN BE ATTRIBUTED TO MISALIGNMENT DURING CONNECTION ATTEMPTS BETWEEN THE METAL RECEPTACLES ON THE CONTROLLER AND THE PLASTIC CONNECTOR PLUGS IN THE BATTERY AND/OR ADAPTER CABLES. THE MISALIGNMENT RESULTS IN WEAR ON THE CONNECTOR PLUGS THAT CAN LEAD TO CONTACT BETWEEN THE CONNECTOR PLUG AND SOCKET PINS FROM THE CONTROLLER. THE SOCKET PINS MAY NOT WITHSTAND APPLIED FORCES FROM SUBSEQUENT MISALIGNED CONNECTIONS, CAUSING THE PINS TO BEND. BENT PINS ON THE CONTROLLER¿S POWER PORT AND/OR THE BATTERY CONNECTORS WILL RESULT IN THE INABILITY OF THE CONTROLLER TO RECOGNIZE THE CONNECTED POWER SOURCE. THE INABILITY OF THE CONTROLLER TO DETECT/RECOGNIZE A POWER SOURCE WILL RESULT IN A POWER DISCONNECT ALARM. A POSSIBLE ROOT CAUSE OF THE REPORTED POWER SOURCE BENT PINS EVENT CAN BE ATTRIBUTED, BUT NOT LIMITED, TO CONNECTOR DAMAGE, BENT PINS, AND/OR CONNECTOR WIRING FAILURE. ADDITIONAL PRODUCTS: D4: UNK BATTERY H6: FDA METHOD CODE(S): B17 H6: FDA RESULTS CODE(S): C20 H6: FDA CONCLUSION CODE(S): D14 D4: UNK BATTERY H6: FDA METHOD CODE(S): B17 H6: FDA RESULTS CODE(S): C20 H6: FDA CONCLUSION CODE(S): D14 INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.