PATIENT CABLE

Additional Manufacturer Narrative

PRODUCT ANALYSIS: ANALYSIS WAS ABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE PATIENT CABLE WAS FRAYED AT DISTAL END AS THE CABLE INSULATION WERE PULLED FROM HEART LEAD CONNECTOR AND THE BLACK AND RED WIRES WERE EXPOSED BY COLLAR. IT WAS DETERMINED AT ANALYSIS THAT BOTH BLACK (-) AND RED WIRE (+) WIRE FAILED THE CONTINUITY TEST. 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 THE PATIENT CABLE WAS FRAYED AT DISTAL END. THE CABLE HAS BEEN RETURNED FOR EVALUATION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.