BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1022900 · Received March 28, 2008

    Report

    Report Number
    6000153-2008-01685
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 29, 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 Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED A RETURN OF TREMOR AND FREEZING ON THE LEFT SIDE OF THE BODY AND PROBLEMS WITH SPEECH. THE PT WAS TRAVELING WHEN THE SYMPTOMS BEGAN. F/U WITH THE PT'S HCP INDICATED THE PT HAS HAD GOOD OUTCOMES FROM DBS THERAPY UNTIL RECENTLY WHEN HE LOST EFFICACY OVER THE LEFT SIDE OF THE BODY. IN ADDITION, BOTH OF THE IPG DEVICES WERE NEAR BATTERY DEPLETION AND NEEDED REPLACEMENT. THE SYMPTOMS BEGAN WHILE TRAVELING. IN THE AIRPORT THE PT BEGAN HAVING INCREASE OF PARKINSON'S SYMPTOMS ON THE LEFT SIDE. THE PT BEGAN TO HAVE DIFFICULTY WALKING AND LATER BOTHERED BY RIGIDITY, TREMOR, AND BRADYKINESIA ON THE LEFT SIDE. THE SYS WAS INTERROGATED AND SHOWED"BREAKS" ON THE RIGHT SIDE. THE PT WAS TREATED WITH SINEMET TO COMPENSATE FOR THE LACK OF EFFECT FROM THE SYS. ON EXAM, THE PT EXHIBITED HYPOPHONIA, DYSARTHRIA, AND, AFTER AN INCREASE IN THE SINEMET DOSE, SOME MENTAL STATUS CHANGES (UNSPECIFIED). MUSCLE STRENGTH WAS 5/5 FOR BOTH UPPER AND LOWER EXTREMITIES, MUSCLE TONE WAS NORMAL AND WITHOUT EVIDENCE OF ATROPHY, COGWHEELING: WAS MODERATE BILATERALLY, TREMOR: RESTING MODERATE ON THE LEFT. THE PT HAD MODERATE GAIT SHUFFLING. AN X-RAY WAS PERFORMED AND WAS SUSPICIOUS FOR DBS LEAD BREAKAGE BUT WAS NOT CONCLUSIVE. THE HCP PLANNED TO SURGICALLY REPLACE BOTH IPGS. DURING THE PROCEDURE, THE RIGHT EXTENSION WILL BE TESTED AND REPLACED IF NECESSARY. IF THE BREAK IS LOCALIZED TO THE DBS ELECTRODE, ANOTHER SURGERY WITH STEREOTACTIC FRAME WILL BE REQUIRED. THE PT'S CONCOMMITANT MEDICATIONS INCLUDE: SINEMET, METOPROLOL, VITAMIN B12 INJECTION, CARBIDOPA-LEVODOPA, SELEGILINE HCL, GLUCOPHAGE, LIPITOR, SENNA LEAVES, OCUPRESS 1% EYE DROPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 3387 J042785252V

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention PROGRAMMER MODEL 7438 LOT# NHL011355P| IMPLANTED| EXPLANTED| EXPLANTED| EXTENSION MODEL 7482 LOT # NHU056626V| IMPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| IMPLANTED| IPG MODEL 47426| EXPLANTED| EXTENSION MODEL 7482 LOT# NHU059800V| IMPLANTED| IMPLANTED| LEAD MODEL 3387 LOT# J0437135V| IPG MODEL 7426| EXPLANTED