BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD (X2)

    MDR report key: 1052744 · Received May 23, 2008

    Report

    Report Number
    6000153-2008-02762
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Report Date
    April 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT DOES NOT RECEIVE GOOD THERAPEUTIC EFFECT WITH THE RIGHT NEUROSTIMULATOR. THE PT'S SPEECH IMPROVES WITH THE NEUROSTIMULATOR OFF, HOWEVER, THE PT'S TREMOR RETURNS. THE PT EXPERIENCES SOME LEG DYSTONIA ON THE RIGHT SIDE (LEFT NEUROSTIMULATOR). AT THE TIME OF THIS REPORT THE PT WAS AT THE CLINIC, IN FAIR CONDITION. IMPEDANCE READINGS WERE GREATER THAN 2000 OHMS ON BOTH SIDES. X-RAY OF THE SYSTEM DID NOT REVEAL ANY OBVIOUS ISSUES. THERAPY IMPEDANCES WERE 828 WITH A CURRENT OF 42 MA, AND 1392 WITH A CURRENT OF 27 MA. THE HCP MENTIONED THE LEAD WAS NOT IN THE OPTIMAL LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD (X2) MHY MEDTRONIC PUERTO RICO OPERATIONS CO 3387 J0555411V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTABLE NEURO STIMULATOR MODEL 7426| EXPLANTED| EXTENTION MODEL 7482 LOT# NHU114633V| EXPLANTED| EXTENSION MODEL 7482 LOT# NHU114632V| IMPLANTABLE NEURO STIMULATOR MODEL 7426| EXPLANTED| LOT# NFW131935H| LOT# NFW131936H| EXPLANTED