BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT RF DR

    MDR report key: 3801273 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10934
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    March 5, 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
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYMPTOMATIC PATIENT PRESENTED TO CLINIC AFTER RECEIVING INAPPROPRIATE HV THERAPY. UPON INVESTIGATION, THE DEVICE REPORTED AN OVER CURRENT DETECTION ERROR. THE RV LEAD WAS CAPPED DUE TO FRACTURE. THE DEVICE REMAINS IMPLANTED AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278688 CURRENT RF DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR (B)(4)