BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF DR

    MDR report key: 1955120 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00133
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 11, 2010
    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
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED HARDWARE RESET WAS VERIFIED IN THE LABORATORY AND WAS DUE TO A POR (POWER-ON-RESET). THE BATTERY VOLTAGE AT THE TIME OF RESET WAS 3.098V, WHICH INDICATES THAT THE BATTERY WAS NOT THE CAUSE OF THE POR. REVIEW OF THE STORED EGM FOUND NOISE CONSISTENT WITH LEAD DAMAGE, WHICH RESULTED IN INAPPROPRIATE THERAPY. IT IS BELIEVED THAT THE POR OCCURRED DUE TO INAPPROPRIATE HV THERAPY ENGERGY GOING THROUGH DAMAGED LEADS. AFTER CLEARING THE RESET, THE DEVICE'S FUNCTIONALITY WAS TESTED AND NO ANOMALY WAS DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED TWO SHOCKS FOLLOWED BY A PATIENT NOTIFIER VIBRATION. THE PATIENT PRESENTED TO THE CLINIC, AND UPON INTERROGATION, THE DEVICE WAS FOUND TO BE IN BVVI MODE. DEVICE IMAGE SHOWED A POWER-ON-RESET HAD OCCURRED AND ALSO, THE PATIENT HAD MULTIPLE DETECTIONS PRIOR TO THE HV THERAPY. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT RF DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention 7020/60, (B)(4), 1888TC/52, (B)(4)