SENSIGHT

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

ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. NO DAMAGE TO CABLE WAS OBSERVED. IT WAS DETERMINED THAT THE HIGH RESISTANCE VALUE WAS NOT CAUSED BY THE CABLE OR LEAD, BUT BY THE HIGH RESISTANCE VALUE ON THE BIOLOGICAL SIDE. THE HIGH RESISTANCE ITSELF HAS NOT BEEN ELIMINATED.

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 DURING THE LEAD IMPLANTATION PROCEDURE, THE LEAD TEST CABLE WAS USED TO MEASURE LEAD IMPEDANCE VALUES. SOME OF THE ELECTRODES CONTINUED TO SHOW HIGH RESISTANCE VALUES DESPITE REPEATED RE-CONNECTIONS WITH MANY INITIAL HIGH IMPEDANCE ELECTRODES. A NEW CABLE WAS USED, HOWEVER, SOME OF THE HIGH IMPEDANCES DID NOT CHANGE, AND THE OPERATION CONTINUED. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.