BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 3861525 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01439
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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 WAS REPLACED DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI). THE BATTERY LONGEVITY WAS LESS THAN THE PHYSICIAN'S EXPECTATION. THE DEVICE WAS REMOVED AND A NEW DEVICE WAS IMPLANTED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342178 INSYNC SENTRY DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND 7298

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R