BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF PACEMAKER

    MDR report key: 5919650 · Received August 31, 2016

    Report

    Report Number
    2938836-2016-10899
    Event Type
    Malfunction
    Date Received
    August 31, 2016
    Date of Event
    July 22, 2016
    Report Date
    July 22, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWP
    PMA / PMN Number
    P030035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT PRESENTED FOR FOLLOW-UP IN CLINIC, A MESSAGE FOR ERI REACHED BEFORE THE DEVICE IMPLANT DATE WAS OBSERVED. DEVICE IMAGE WAS NOT SAVED DUE TO SLOW TELEMETRY SPEED. ON (B)(6) 2016, AN EOS MESSAGE WAS NOTED. DEVICE DOWNLOAD WAS PERFORMED AND DEVICE FUNCTION WAS RESTORED. PATIENT'S CONDITION WAS STABLE AND THE PATIENT WILL BE FOLLOWED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570929 ACCENT DR RF PACEMAKER IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) PM2210 3091669

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR