BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURITY PLUS DR RF

    MDR report key: 3920729 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14335
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 14, 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 Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING THE IMPLANT PROCEDURE, IT WAS DIFFICULT TO INSERT THE LEAD INTO THE PULSE GENERATORS HEADER. AFTER ADDITIONAL ATTEMPTS, THE LEAD COULD BE INSERTED. THE ELECTRICAL VALUES WERE TESTED AND WERE FOUND TO BE IN NORMAL RANGE. THE DEVICE WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396417 ASSURITY PLUS DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2260 NA

    Patients

    Seq Age Sex Outcome Treatment
    1