BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC III PROTECT

    MDR report key: 3152112 · Received June 7, 2013

    Report

    Report Number
    9614453-2013-01078
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    February 28, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR DUE TO POSSIBLE PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. DURING THE REPLACEMENT PROCEDURE, THE PHYSICIAN FOUND THAT THE ATRIAL LEAD THRESHOLD HAD INCREASED. A NEW LEAD WAS ATTEMPTED TO BE IMPLANTED, BUT FAILED. THAT LEAD WAS NOT USED AND THE EXISTING LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252802 INSYNC III PROTECT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND 7285

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 4574 IMPLANTABLE LEAD