BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURITY SR

    MDR report key: 3920722 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14320
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 29, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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. EVALUATION DESCRIPTION: ANALYSIS FOUND NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED LOSS OF VENTRICULAR OUTPUT. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396395 ENDURITY SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM1160 NA

    Patients

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