PATIENT CABLE

Description of Event or Problem

IT WAS FURTHER REPORTED THAT THE CONNECTION BETWEEN THE PATIENT CABLE AND THE TEMPORARY LEAD HAD A TENDENCY TO BECOME LOOSE. IT WAS NOTED THAT THE PATIENT WAS TREATED IN THE INTENSIVE CARE UNIT (ICU). WHILE THE PATIENT WAS EXPERIENCING AGITATION OR RESTLESSNESS, THE CABLE CONNECTION POINT TO THE TEMPORARY LEAD DETACHED, RESULTING IN A DECREASED PACING RATE. TROUBLESHOOTING STEPS WERE TAKEN TO RECONNECT THE CABLE, WHICH RESOLVED THE ISSUE. HOWEVER, IT WAS FURTHER NOTED THAT EVEN AFTER THE EVENT, THE LEAD-TO-CABLE CONNECTION REMAINED LOOSE AND DETACHED AGAIN.

Additional Manufacturer Narrative

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Additional Manufacturer Narrative

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT CABLE WAS FAULTY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

PRODUCT ANALYSIS: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER'S COMMENT THAT THE PATIENT CABLE WAS FAULTY. THE PATIENT CABLE PASSED ALL VISUAL INCOMING INSPECTION WITH NO ANOMALIES FOUND. ALL CONTINUITY TESTS ON THE PATIENT CABLE WERE PASSED. THERE WAS NO INTERMITTENT OR SHORTED CONNECTIONS FOUND. IN THE TWO BLACK TEMPORARY ADAPTORS, ONLY THE BOTTOM ONE-SIXTH OF THE PIN CONNECTED TO THE HEART-LEAD CONNECTOR. WHEN MOVED, THE PINS DISCONNECTED FROM THE HEART-LEAD CONNECTOR. ONE OF THE PIN WAS MISSING THE LOCK SCREW. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.