PATIENT CABLE

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT CABLES WERE UNABLE TO BE EFFECTIVELY CONNECTED TO THE COMPETITOR FLOW DIRECTED PACING CATHETER. IT WAS NOTED THAT IT WAS POSSIBLE TO DISLODGE THE CONNECTION BETWEEN THE PATIENT CABLE AND PACING CATHETER AFTER BEING TWISTED OR MOVED. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

PRODUCT ANALYSIS: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER'S COMMENT THAT THE PATIENT CABLE WAS UNABLE TO BE EFFECTIVELY CONNECTED TO THE COMPETITOR FLOW-DIRECTED PACING CATHETER. THE CABLE PASSED ALL VISUAL INCOMING INSPECTION WITH NO ANOMALIES FOUND. 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.