BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1203505 · Received October 17, 2008

    Report

    Report Number
    3004209178-2008-06633
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED UPON REMOVING THE LEAD CAP, THE # 0 CONTACT WAS DAMAGED DURING STAGE 2 DEEP BRAIN STIMULATION SURGERY TO CONNECT THE PT'S LEAD TO AN EXTENSION AND ULTIMATELY THE STIMULATOR. THIS LEAD HAD BEEN IMPLANTED IN THE SUBTHALAMIC NUCLEUS (STN) OF THE PTS LEFT BRAIN. THE SURGEON WAS ABLE TO GET THE # 0 CONTACT LINED UP WITH THE CORRESPONDING SET SCREW OF THE EXTENSION. HOWEVER, UPON TESTING THE IMPEDANCE OF THE SYSTEM INTRA-OPERATIVELY, ALL COMBINATIONS INVOLVING # 0 CONTACT WERE OVER 4000 OHMS. THE SURGERY WAS COMPLETED. THE PROGRAMMING TEAM AT THE HOSP WAS NOTIFIED AND THEY WERE GOING TO TRY TO PROGRAM AROUND THE # 0 CONTACT WHILE ATTEMPTING TO MAXIMIZE THE EFFICACY OF THE THERAPY. THE ULTIMATE OUTCOME IS UNK AT THIS TIME. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR PROGRAMMER: MODEL 7436| LEAD: MODEL 3389| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482| IMPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| IMPLANTED: