BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D

    MDR report key: 3220156 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04531
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 11, 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
    NY
    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

    UPON RECEIPT, THE DEVICE WAS FOUND TO BE IN BACKUP PACING WITH HV THERAPY ENABLED. THE CAUSE OF THE BACKUP MODE WAS TWO CONSECUTIVE RESETS DUE TO EXCESSIVE HV CHARGING. BASED ON DEVICE SETTINGS, A LONGEVITY CALCULATION WAS PERFORMED AND FOUND TO BE WITHIN EXPECTED LIMITS. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING A SHOCK. INTERROGATION SHOWED THE DEVICE WAS IN BACKUP STATUS. FURTHER REVIEW OF EPISODES SHOWED MULTIPLE CHARGES WHICH LIKELY DEPLETED THE BATTERY. DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320190 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention