BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURITY DR RF

    MDR report key: 3923116 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14452
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 9, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 DURING THE IMPLANT PROCEDURE, IT WAS DIFFICULT TO INSERT THE LEADS INTO THE PULSE GENERATOR HEADER. AFTER USING SILICONE OIL THE LEADS WERE INSERTED INTO THE HEADER AND WERE FUNCTIONING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401771 ASSURITY DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2240 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR