BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF PACEMAKER

    MDR report key: 4811711 · Received June 2, 2015

    Report

    Report Number
    2017865-2015-07077
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 1, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P030035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED HIGH VENTRICULAR RATE AND VENTRICULAR NOISE EPISODES. THE DEVICE WAS REPROGRAMMED. THE PATIENT EXPERIENCED NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356196 ACCENT DR RF PACEMAKER IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2210 2885382

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR