PATIENT CABLE

Additional Manufacturer Narrative

PRODUCT ANALYSIS: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT OF THE CABLE CONNECTOR'S CONNECTION BECAME LOOSE WITH THE TEMPORARY PACEMAKER PORT AND THE TEMPORARY PACEMAKER WAS UNABLE TO PACE EFFECTIVELY. IT WAS NOTED THAT THE HEART LEAD CONNECTOR WAS CONT AMINATED(ADHESIVE) AND THE POSITIVE AND NEGATIVE HEART LEAD INSERTS WERE ALSO CONTAMINATED INSIDE. ADDITIONALLY, IT WAS NOTED THAT ALL CONTINUITY TESTS WERE OKAY AND NO INTERMITTENT OR SHORTED CONNECTIONS WERE FOUND. 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.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A FAILURE OF THE PATIENT CABLE CONNECTOR, THE CONNECTION BECAME LOOSE WITH THE TEMPORARY PACEMAKER PORT AND THE TEMPORARY PACEMAKER WAS UNABLE TO PACE EFFECTIVELY. THE PATIENT EXPERIENCED COMPLETE HEART BLOCK. ANOTHER PATIENT CABLE WAS CONNECTED TO THE TEMPORARY PACEMAKER TO PROVIDE PACING SUPPORT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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.