BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D

    MDR report key: 3090081 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01218
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    March 6, 2013
    Report Date
    August 1, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND WAS FOUND TO BE NORMAL. THE ORIGINAL BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER EVALUATION AND NO ANOMALY WAS FOUND. THE CAUSE OF THE PREMATURE BATTERY DEPLETION COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER AND (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP, IT WAS OBSERVED THAT THE DEVICE HAD PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192585 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention