BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 2952317 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00107
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 16, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    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 WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE. THE PROGRAMMER DATA SHOWS THE TIME OF ELECTIVE REPLACEMENT INDICATOR (ERI) ON (B)(6) 2012. ERI LESS THAN OR EQUAL TO 2.62 VOLT, AND REACHED END OF LIFE THREE MONTHS AFTER ERI. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS BATTERY WAS 2.64 TO 2.62 VOLTS BETWEEN (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY # THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID NOT MEET EXPECTED LONGEVITY. THE ICD 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
    56562 INSYNC SENTRY DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND 7298

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR