BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT DR RF

    MDR report key: 3953161 · Received July 23, 2014

    Report

    Report Number
    2938836-2014-13636
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 3, 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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED INABILITY TO COMMUNICATE AND INAPPROPRIATE THERAPY DELIVERY WERE NOT CONFIRMED IN THE LABORATORY. THE DEVICE WAS ABLE TO COMMUNICATE NORMALLY. THE STORED ELECTROGRAMS WERE REVIEWED AND THE THERAPIES DELIVERED WERE DEEMED APPROPRIATE. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT, AND NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ER WITH MULTIPLE ACTIVE INAPPROPRIATE HV THERAPIES. A MAGNET WAS PLACED TO PREVENT FURTHER THERAPIES. REVIEW OF SURFACE ECG SHOWED THE PATIENT WAS EXHIBITING TWO TO ONE CONDUCTION. THE DEVICE WAS UNABLE TO BE INTERROGATED AFTER MULTIPLE ATTEMPTS. IT WAS NOTED THAT THE PATIENT HAD BEEN LOST TO FOLLOW UP. DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431553 CURRENT DR RF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention