BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT ACCEL DR

    MDR report key: 4031741 · Received August 22, 2014

    Report

    Report Number
    2938836-2014-14759
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    July 1, 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
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. REF MDR 2938836-2014-13762 FOR MDR REGARDING PATIENT DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MERLIN.NET TRANSMISSION INDICATED THAT THE DEVICE HAD GONE INTO BACKUP VVI MODE. IT WAS NOT KNOWN IF THE ALERT WAS VALID. HOWEVER, IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED A NOTICEABLE INCREASE IN THE AMOUNT OF APPROPRIATE THERAPY IN THE WEEKS PRIOR TO THE EVENT. THE PHYSICIAN REQUESTED THAT THE PATIENT COME TO THE CLINIC FOR REVIEW, BUT THE PATIENT REFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509355 CURRENT ACCEL DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2215-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR