PATIENT CABLE

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 THE PATIENT CABLES DID NOT WITHSTAND MORE THAN 20 CYCLES OF STEAM STERILIZATION, WHICH WAS USED AS THE CLEANING PROCEDURE. IT WAS NOTED THAT THE CABLES WERE DAMAGED, SPECIFICALLY BROKEN AT THE END, LEAVING THE WIRE EXPOSED. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

PRODUCT ANALYSIS: ANALYSIS WAS ABLE TO CONFIRM THE CUSTOMER'S COMMENT THAT THE PATIENT CABLES WERE DAMAGED, SPECIFICALLY BROKEN AT THE END, LEAVING THE WIRE EXPOSED. IT WAS NOTED THAT THE OUTSIDE CABLE INSULATION WAS OPEN FROM THE HEART LEAD CONNECTOR, EXPOSING INTERNAL RED AND BLACK WIRES. ADDITIONALLY, IT WAS NOTED THAT THE INSULATION WAS BUNCHED TOGETHER BY THE EXTERNAL PULSE GENERATOR (EPG) CONNECTOR. ALSO, THE CABLE INSULATION WAS CUT/DAMAGED APPROXIMATELY 24.5 INCHES FROM THE PLUG. IT WAS NOTED THAT THE CABLE WAS TWISTED IN FOUR LOCATIONS. ALL CONTINUITY TESTS WERE OKAY, AND NO INTERMITTENT OR SHORTED CONNECTIONS WERE OBSERVED. 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.