BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF VR

    MDR report key: 3220089 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04130
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    April 19, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THAT THE PATIENT PRESENTED TO THE ER AFTER RECEIVING SEVERAL INAPPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE DETECTED AS VENTRICULAR FIBRILLATION. DESPITE PROGRAMMING CHANGES, THE PATIENT STILL RECEIVED INAPPROPRIATE THERAPY. THE PATIENT HAD AN AV NODE ABLATION PROCEDURE, AND DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING MULTIPLE INAPPROPRIATE THERAPY SHOCKS FOR SVT AND THAT THE DEVICE HAD REACHED THE CAPACITOR CHARGE TIME LIMIT AT THE END OF MULTIPLE THERAPIES. PROGRAMMING CHANGES WERE RECOMMENDED. IT WAS ALSO REPORTED THAT THE DEVICE INCORRECTLY SHOWED ALERT FOR A CAPACITOR CHARGE TIME LIMIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320944 CURRENT RF VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention