BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF PACEMAKER

    MDR report key: 5131417 · Received October 7, 2015

    Report

    Report Number
    2017865-2015-29221
    Event Type
    Malfunction
    Date Received
    October 7, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 6, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P030035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE PULSE GENERATOR EXHIBITED OVERSENSING. THE DEVICE WAS REPROGRAMMED. NO PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663880 ACCENT DR RF PACEMAKER IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2210 3729156

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR