BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE PLUS CRT-D, DF-4 CONNECTOR

    MDR report key: 3914574 · Received July 3, 2014

    Report

    Report Number
    2938836-2014-13174
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 23, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. BASED ON ALL AVAILABLE PARAMETER AND USAGE INFORMATION, DEVICE LONGEVITY WAS FOUND TO BE BELOW THE EXPECTED LIMITS. WITH AN EXTERNAL POWER SUPPLY ATTACHED, THE DEVICE FUNCTIONED NORMALLY. NO HIGH CURRENT WAS DETECTED DURING TESTING AND THE POWER CONSUMPTION WAS NORMAL. THE ORIGINAL BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER EVALUATION AND NO ANOMALY WAS FOUND. THE ROOT CAUSE OF THE PREMATURE BATTERY DEPLETION COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY IS DEPLETING FASTER THAN EXPECTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DEVICE REMAINS IMPLANTED. PATIENT WAS RECENTLY SCHEDULED FOR A FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389813 PROMOTE PLUS CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention