BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1033617 · Received April 24, 2008

    Report

    Report Number
    6000153-2008-02181
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 25, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED AT FOLLOW-UP THAT THE PT HAD EXPERIENCED INTERMITTENT SIDE AFFECTS OF SLURRED SPEECH AND FACIAL SPASM (DATES OF ONSET WERE NOT PROVIDED). THIS HAD BEEN OBSERVED WITH PT SITTING QUIETLY AND NO POSITIONAL MOVEMENTS AT ALL. IT WAS UNK IF THE EVENTS WERE ATTRIBUTABLE TO THE IMPLANTED SYSTEM OR IF THEY WERE NEW SYMPTOMS; THE PT HAD NOT PREVIOUSLY BEEN EVALUATED AT THE USER FACILITY AND COULD NOT PROVIDE AN ADEQUATE HISTORY TO THE HCP. UPON INTERROGATION, ACCEPTABLE IMPEDANCE VALUES (NOT GIVEN) HAD BEEN OBTAINED. THE SETTINGS FOR THE LEFT-SIDED PULSE GENERATOR WERE REPORTED AS C+, 1-, 3.4 V, 60 PW, WITH 185 RATE; SETTINGS FOR THE RIGHT-SIDED PULSE GENERATOR WERE REPORTED AS 4+, 5-, 4.2 V, 180 PW, 185 RATE. WHEN TITRATING THE RIGHT SIDE UP TO 4.7 V USING THE PHYSICIAN PROGRAMMER, THE HCP RECEIVED A CHARGE DENSITY WARNING WHICH WAS APPROPRIATE FOR THE SETTINGS. AS THEY TRIED TO PROGRAM TO 1.0V AND BEYOND THEY GOT CHARGE DENSITY WARNING WITH SOME PARAMETERS. TRIED ANOTHER 8840 PROGRAMMER AND WERE ABLE TO REPRODUCE THE WARNING. THEY EVENTUALLY CHECKED C+ AND 6- AGAIN AT WHICH TIME THE ISSUE WAS RESOLVED AND THEY NO LONGER GOT THE CHARGE DENSITY WARNING AT 1.0V AND ABOVE. RESULTS OF X-RAY EXAM OBTAINED IN 2008, HAD NOT DETECTED ANY ABNORMALITIES. ADD'L INFO HAS BEEN REQUESTED FROM THE PHYSICIAN. REFER TO MFR REPORT # 6000153200802184.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 3387 V007613

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTENSION MODEL 7482 LOT# NHU126657V IMPLANTED| EXTENSION MODEL 7482 LOT# NHU108771V IMPLANTED| EXPLANTED| EXPLANTED| LOT# NFD102675H IMPLANTED| IMPLANTABLE NEURO STIMULATOR MODEL 7428| EXPLANTED| PROGRAMMER MODEL 7436 LOT# NFU013337P