BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2115229 · Received May 27, 2011

    Report

    Report Number
    3007566237-2011-03840
    Event Type
    Injury
    Date Received
    May 27, 2011
    Date of Event
    August 24, 2009
    Report Date
    May 21, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P96009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUMMARY: THIS ARTICLE DISCUSSED A CASE OF DISRUPTION OF THE INSULATION OF AN EXTENSION WIRE IN A (B)(6) FEMALE PT WITH FAMILIAL ESSENTIAL TREMOR (ET), WHO HAD PRESENTED WITH MARKED ACTION TREMOR AND A MODERATE RESTING TREMOR OF BOTH HANDS. THE PT HAD UNDERGONE SURGERY FOR BILATERAL DEEP BRAIN STIMULATION (DBS) OF THE VENTROLATERAL THALAMUS AT THE AGE OF (B)(6). AFTER 30 MONTHS, THE IMPULSE GENERATOR (IPG) BATTERY WAS LOW AND THE PT UNDERWENT REPLACEMENT SURGERY WITH THE SAME IPG MODEL. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME NO ADD'L INFO WAS AVAILABLE.

    Description of Event or Problem · 1

    LITERATURE: WACHTER T, WEISS D, BREIT S, GASSER T, KRUGER R, GHARABAGHI A. SEVERE MUSCULAR FASCICULATIONS AS AN UNCOMMON SIDE-EFFECT DUE TO MICRODEFECT OF AN EXTENSION WIRE IN DEEP BRAIN STIMULATION. MOV DISORD. OCT 30 2009;24(14):2161-2162. EVENT: A FEW DAYS AFTER THE REPLACEMENT SURGERY, THE PT EXPERIENCED TINGLING SENSATIONS IN THE LEFT SUBCLAVICULAR REGION UNDER THE IPG AND PAIN RADIATING FROM THE STERNUM TO THE LEFT SHOULDER. OVER THE NEXT FEW WEEKS, THE PT EXPERIENCED AN INCREASE OF PARESTHESIAS, INTERMITTENT TWITCHING MOVEMENTS NEXT TO THE IPG, AND DULL PAIN IN THE LEFT SHOULDER. THERE WERE FASCICULATIONS OF VARYING DEGREE OVER THE LEFT PECTORAL MUSCLE WHICH INCREASED WHEN GENTLE PRESSURE WAS EXERTED ON THE LATERAL SIDE OF THE IPG. THE PT'S CLINICAL RESPONSE STILL WAS GOOD, AND IMPEDANCE AND CURRENT READINGS WERE NORMAL. AN X-RAY SHOWED THAT THE IPG AND EXTENSIONS WERE IN THE CORRECT POSITION. TROUBLESHOOTING WAS ATTEMPTED WHICH REVEALED THAT THE FASCICULATIONS STOPPED WHEN THE ELECTRODE OF THE LEFT HEMISPHERE WAS TURNED OFF. A SURGICAL EXPLORATION WAS PERFORMED DURING WHICH THE EXTENSION WIRES WERE DISCONNECTED AND TESTED AND VISUALLY INSPECTED INTRAOPERATIVELY REVEALING NO CONSPICUOUS DEFECT. A SURGICAL MICROSCOPE THEN WAS USED TO INSPECT THE EXTENSION WIRES NEXT THE IPG AND DISCLOSED A MINIMAL DISCONTINUITY OF THE INSULATION OF THE LEFT EXTENSION WIRE. THE INSULATION WAS RESTORED WITH SILICONE GLUE AND A SEALING CAP. AFTER THE SURGERY AND FOR THE FOLLOWING 3 MONTHS, THE PT HAD NO MORE FASCICULATIONS OR SHOULDER PAIN AND THE TREMOR WAS SUPPRESSED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC NEUROMODULATION 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention EXPLANTED:| LEAD: MODEL: LEADMVD, LOT # UNK| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL: LEADMVD, LOT # UNK| EXTENSION: MODEL: EXTENSION MVD, LOT # UNK| IMPLANTED:| EXTENSION: MODEL: EXTENSION MVD, LOT # UNK