BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2201336 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01183
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 6, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT WHEN THE PROGRAMMER, DURING AN ATTEMPTED INTERROGATION OF AN IMPLANTABLE CARDIAC DEFIBRILLATOR, THE PROGRAMMER HAD AN ERROR MESSAGE. THE POWER WAS RECYCLED HOWEVER THE ERROR OCCURRED AGAIN. THERE IS ANOTHER PROGRAMMER THAT THE CLINICIAN COULD USE. A SERVICE DISK WAS GOING TO BE RUN AT A LATER DATE TO CLEAR THE ERROR. A SERVICE DISKETTE WAS REQUESTED TO CLEAR THE ERROR. IF THE ISSUE PERSISTS THE PROGRAMMER WILL BE RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAMMER KRG MEDTRONIC, INC. 2090 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other