BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA

    MDR report key: 2955375 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02079
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 5054 IMPLANTABLE PACING LEAD (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE BATTERY MEASUREMENTS WERE NOT AVAILABLE FOLLOWING THE SCAN AND HAD BEEN MEASURED AT 2.64 VOLTS PRIOR TO THE SCAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PATIENT HAD A MAGNETIC RESONANCE IMAGING SCAN DONE OF THEIR BRAIN, THE DEVICE WAS FOUND TO HAVE HAD AN ELECTRICAL RESET. ALSO THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE HAD INCREASED BY APPROXIMATELY 54 OHMS. IT WAS NOTED THE THRESHOLDS WERE UNCHANGED AFTER THE SCAN. THE RESET WAS CLEARED AND THE DEVICE AND RV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57943 KAPPA PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC MED REL MEDTRONIC PUERTO RICO KDR901

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention 5076 IMPLANTABLE PACING LEAD