BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D

    MDR report key: 3080164 · Received April 26, 2013

    Report

    Report Number
    2938836-2013-01012
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    January 8, 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
    FL
    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. BASED ON THE AVAILABLE PARAMETER AND USAGE INFORMATION, A LONGEVITY CALCULATION WAS PERFORMED AND WAS FOUND TO BE BELOW THE EXPECTED LIMITS. 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

    THE REPORTED PREMATURE BATTERY DEPLETION COULD NOT BE CONFIRMED IN THE LABORATORY. WITH AN EXTERNAL POWER SOURCE ATTACHED. THE DEVICE FUNCTIONED NORMALLY WHEN TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT. THE ORIGINAL BATTERY WAS SENT TO THE VENDOR FOR FURTHER EVALUATION AND NO ANOMALIES WERE OBSERVED. THE CAUSE OF THE PREMATURE BATTERY DEPLETION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT FOR ERI WAS RECEIVED VIA (B)(6). ONE MONTH LATER AT CHANGE-OUT, THE DEVICE WAS NOT ABLE TO BE INTERROGATED. THE DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    ALSO NOTED WAS EXCESSIVE BATTERY DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182594 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention