PATIENT CABLE

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT CABLE PLUG HAD A LOOSE CONNECTION AND WAS UNABLE TO REMAIN SECURELY HELD TO THE EXTERNAL PULSE GENERATOR (EPG) CONNECTOR, WHICH PREVENTED PROPER SENSING AND PACING. TROUBLESHOOTING STEPS WERE TAKEN, INCLUDING TESTING THREE OTHER CABLES OF THE SAME MODEL AND LOT, ALL OF WHICH EXHIBITED THE SAME ISSUE. FURTHER TROUBLESHOOTING STEPS INCLUDED USING AN ALTERNATIVE MODEL CABLE, WHICH FUNCTIONED NORMALLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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.