BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 2812839 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06369
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    November 28, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 THE DEVICE WENT TO ELECTIVE REPLACEMENT INDICTOR (ERI) EARLY AT APPROXIMATELY 3 YEARS AND 3 MONTHS AND STOPPED WORKING. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WENT TO ELECTIVE REPLACEMENT INDICTOR (ERI) EARLY AT APPROXIMATELY 3 YEARS AND 3 MONTHS AND STOPPED WORKING. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC SENTRY DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL, INC. 7299

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R 4193 IMPLANTABLE PACING LEAD| 6932 IMPLANTABLE TACHY LEAD