PATIENT CABLE

Additional Manufacturer Narrative

PRODUCT ANALYSIS: IT WAS DETERMINED AT ANALYSIS THAT THE HEART LEAD CONNECTORS POSITIVE (RED) KNOB ASSEMBLY WAS BROKEN OFF. ADDITIONALLY, IT WAS NOTED THAT THE CABLE INSULATION IS PULLED FROM THE HEART LEAD CONNECTOR STRAIN RELIEF BY QUARTER INCH EXPOSING THE RED AND BLACK WIRES. ALL CONTINUITY TESTS WERE PASSED 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

THE CABLE WAS RETURNED FOR EVALUATION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.