BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT ACCEL DR

    MDR report key: 3884811 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12114
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 14, 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
    IT
    Reporter Occupation
    PHYSICIAN

    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 THE DEVICE WAS OVERSENSING ON BOTH THE ATRIAL AND VENTRICULAR CHANNEL. INTERROGATION REVEALED AN INTERFERENCE EPISODE. PHYSICIAN BELIEVES EMI IS THE CAUSE. PHYSICIAN WILL MONITOR THE PATIENT WITH ROUTINE FOLLOW-UP. THE PATIENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360164 CURRENT ACCEL DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2215-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1