PATIENT CABLE

Additional Manufacturer Narrative

PRODUCT ANALYSIS: AT ANALYSIS IT WAS DETERMINED THAT THE OUTSIDE CABLE INSULATION WAS OPEN APPROXIMATELY 46 INCHES FROM THE PLUG, EXPOSING THE INTERNAL RED AND BLACK WIRES. ALL CONTINUITY TESTS WERE OKAY. THERE WERE NO INTERMITTENT OR SHORTED CONNECTIONS 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 THE PATIENT CABLE DID NOT WITHSTAND MORE THAN 20 CYCLES OF STEAM STERILIZATION, WHICH WAS USED AS THE CLEANING PROCEDURE. THE PATIENT CABLE WAS RETURNED FOR EVALUATION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING THE MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.