PATIENT CABLE

Additional Manufacturer Narrative

PRODUCT ANALYSIS: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT OF THERE WAS A FAILURE OF THE PATIENT CABLE CONNECTION AND THE TEMPORARY PACEMAKER WAS UNABLE TO PACE EFFECTIVELY. IT WAS NOTED THAT THE PLUG CONNECTOR WAS BENT BETWEEN PLUG AND STRAIN RELIEF. ADDITIONALLY, THE HEART LEAD CONNECTOR WAS FOUND CONTAMINATED WITH AN ADHESIVE AND THE CONTAMINATION WAS FOUND INSIDE POSITIVE AND NEGATIVE HEART LEAD INSERTS. ALL FOUND DEFECTIVE PARTS WERE REPLACED AND ALL OTHER IDENTIFIED ISSUES WERE RESOLVED. THE INSTRUMENT THEN PASSED ALL FINAL FUNCTIONAL TESTS. 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.

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.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A FAILURE OF THE PATIENT CABLE CONNECTION AND THE TEMPORARY PACEMAKER WAS UNABLE TO PACE EFFECTIVELY. ANOTHER PATIENT CABLE WAS CONNECTED TO THE TEMPORARY PACEMAKER IN ORDER TO PROVIDE PACING THERAPY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.