PATIENT CABLE

Additional Manufacturer Narrative

PRODUCT ANALYSIS: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER¿S COMMENT THAT THE CABLE DID NOT WORK PROPERLY AND THAT THE ELECTRODES COULD NOT BE MAINTAINED INSIDE THE BOX. THE CABLE PASSED VISUAL INCOMING INSPECTION WITH NO ANOMALIES NOTED. ALL CONTINUITY TESTS PASSED, AND NO INTERMITTENT OR SHORTED CONNECTIONS WERE FOUND. THE INSTRUMENT THEN PASSED ALL FINAL FUNCTIONAL TESTS. 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 CONNECTION OF THE CABLE DID NOT WORK PROPERLY AND THE ELECTRODES COULD NOT BE MAINTAINED INSIDE THE BOX. IT WAS NOTED THAT THE ISSUE OCCURRED AT THE WHITE TRANSPARENT END OF THE CABLE. THERE WAS NO PATIENT INVOLVEMENT.

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.