BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1053225 · Received May 28, 2008

    Report

    Report Number
    6000153-2008-02839
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 28, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IMPEDANCE READINGS GREATER THAN 2000 OHMS WAS REPORTED ON ALL OR SOME OF THE UNIPOLAR PAIRS. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MEDWATCH REPORT # 6000153200802838.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC PUERTO RICO OPERATIONS CO 3387 J0437239V

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED| (NEUROSTIMULATOR| RIGHT DEEP BRAIN STIMULATION SYSTEM| LOT# NFW122533H| EXTENSION MODEL 7482 LOT# NHU061556V| EXPLANTED| IMPLANTABLE NEURO STIMULATOR MODEL 7426