BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC III

    MDR report key: 6161031 · Received December 9, 2016

    Report

    Report Number
    9614453-2016-06928
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    September 28, 2016
    Report Date
    September 30, 2016
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Removal / Correction Number
    Z-0342-2016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS REPORTED AS INCLUDED IN THE FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT CANNOT BE CONFIRMED THAT THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. IT IS INCLUDED IN THE FIELD ACTION IN THE ABUNDANCE OF CAUTION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY FOUND THE ERI (ELECTIVE REPLACEMENT INDICATOR) IS THE RESULT OF HIGH INTERNAL BATTERY RESISTANCE. THIS DEVICE WAS REPORTED AS INCLUDED IN THE FIELD ACTION NOTED AND RETURNED PRODUCT INVESTIGATION FOUND THE DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) REACHED EARLY BATTERY DEPLETION. IT WAS NOTED THE REMAINING BATTERY LONGEVITY DROPPED TO LOWER THAN THE EXPECTED LONGEVITY. THE CRT-P WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810986 INSYNC III PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC EUROPE SARL 8042U

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R