BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT PLUS VR

    MDR report key: 4021787 · Received August 19, 2014

    Report

    Report Number
    2938836-2014-14525
    Event Type
    Malfunction
    Date Received
    August 19, 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
    AK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE MALFUNCTION WAS SUSPECTED. THE DEVICE REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498753 CURRENT PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1211-36 NA

    Patients

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