BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS DR

    MDR report key: 3903618 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12729
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    April 17, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF PROGRAMMER PRINTOUTS. UPON RECEIPT, NO COMMUNICATION COULD BE ESTABLISHED BETWEEN THE DEVICE AND PROGRAMMER. IT IS BELIEVED THE BVVI OPERATION AND NO COMMUNICATION WERE CAUSED BY BATTERY DEPLETION. DEVICE LEVEL TESTING WITH AN EXTERNAL POWER SUPPLY INDICATED NORMAL ELECTRICAL PERFORMANCE. THE ORIGINAL BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER EVALUATION AND NO ANOMALIES WERE FOUND. THE CAUSE OF THE BATTERY DEPLETION WAS NOT DETERMINED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE FOLLOW UP. UPON INTERROGATION, THE DEVICE WAS FOUND TO BE IN BACK UP VVI MODE WITH HIGH VOLTAGE THERAPY DISABLED. THE DEVICE WAS UNABLE TO COMMUNICATE WITH THE PROGRAMMER. THE DEVICE WAS EXPLANTED. PATIENT CONDITION WAS FINE FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381084 CURRENT PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2211-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention