BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 3802539 · Received May 9, 2014

    Report

    Report Number
    2017865-2014-13758
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    March 17, 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
    OR, 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

    NEW INFORMATION RECEIVED ON (B)(6) 2014 NOTES THAT THE PATIENT WAS HAVING AN ABLATION PROCEDURE, THE PULSE GENERATOR TRIPPED ELECTIVE REPLACEMENT INDICATOR DUE TO BEING EXPOSED TO ELECTROCAUTERY. AFTER A PRODUCT CODE DOWNLOAD, THE DEVICE RESUMED NORMALLY FUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED PREMATURE ELECTIVE REPLACEMENT INDICATOR. AFTER A PRODUCT CODE DOWNLOAD THE DEVICE RESUMED NORMAL FUNCTION. THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281836 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR