BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICTORY XL SR

    MDR report key: 4073634 · Received September 9, 2014

    Report

    Report Number
    2017865-2014-16681
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    June 27, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS CONFIRMED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED PREMATURE BATTERY DEPLETION. THE PATIENT WAS NOT DEPENDENT.

    Description of Event or Problem · 1

    NEW INFORMATION NOTED THAT THE DEVICE WAS EXPLANTED IN (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553269 VICTORY XL SR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5610 NA

    Patients

    Seq Age Sex Outcome Treatment
    1