BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY SR

    MDR report key: 3920761 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14351
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 14, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396933 AFFINITY SR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5130 NA

    Patients

    Seq Age Sex Outcome Treatment
    1