BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT SR RF OUS

    MDR report key: 3920797 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14403
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED A PREMATURE ELECTIVE REPLACEMENT INDICATOR. THE DEVICE WAS REPROGRAMMED AND THE PATIENT WAS SENT HOME. A WEEK LATER THE PATIENT WAS PRESENTED TO THE HOSPITAL EXPERIENCING LIGHTHEADEDNESS. UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED A PREMATURE ELECTIVE REPLACEMENT INDICATOR. AFTER CLEARING THE INDICATOR, THE DEVICE REMAINED IMPLANTED. THE POCKET WAS OPENED TO REVISE THE COMPETITOR LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398310 ACCENT SR RF OUS IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM1210 NA

    Patients

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