BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS DR

    MDR report key: 3790934 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10513
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    January 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS OBSERVED ON BOTH CHANNELS OF THE DEVICE. UPON REVIEW OF SESSION RECORDS, MULTIPLE VF EPISODES WITH ABORTED CHARGES WERE SEEN. THE DEVICE WAS FOUND TO BE AT ERI. IT WAS SUSPECTED THAT THE DEVICE REACHED ERI IN (B)(6) 2012. THE DEVICE WAS EXPLANTED AND REPLACED. PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266996 ATLAS PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-243 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR (B)(4)