BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF DR

    MDR report key: 3781727 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-09966
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 10, 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 Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY. REVIEW OF THE DEVICE IMAGE INDICATED THAT A POWER-ON RESET OCCURRED DURING HV THERAPY DELIVERY. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND NO ANOMALY WAS FOUND. THE CAUSE OF THE POWER-ON RESET COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP, THE DEVICE WAS FOUND IN BACKUP VVI MODE. IT WAS NOTED THAT THE PATIENT RECEIVED AN APPROPRIATE SHOCK AND FELT FATIGUED. A DEVICE DOWNLOAD WAS PERFORMED SUCCESSFULLY HOWEVER, THE PHYSICIAN ELECTED TO EXPLANTED AND REPLACED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260717 CURRENT RF DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention