BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT RF DR

    MDR report key: 3920894 · Received July 8, 2014

    Report

    Report Number
    2938836-2014-13348
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP, DEVICE INTERROGATION SHOWED AN EPISODE OF ANTI-TACHYCARDIA PACING THERAPY AS BEING DELIVERED BUT WITH NO EPISODES OF VT/VF. THE DEVICE REPORTED THAT THE DIAGNOSTICS HAD NOT BEEN CLEARED SINCE OVER A YEAR PREVIOUS. REVIEW OF THE RECORDS CONFIRMED THAT THE THERAPY SHOWN WAS A RESULT OF THE DIAGNOSTICS NOT BEING CLEARED. THE DEVICE ALSO SHOWED THAT THERE HAD BEEN ZONE CONFIGURATION CHANGES SINCE THE LAST READ. THE CLINICIAN STATED THAT NO ACTUAL CHANGES WERE MADE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AND THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398279 CURRENT RF DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR