BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1564560 · Received December 14, 2009

    Report

    Report Number
    3007566237-2009-09298
    Event Type
    Injury
    Date Received
    December 14, 2009
    Date of Event
    November 30, 2009
    Report Date
    December 7, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LITERATURE: DELIGNY C, DRAPIER S, VERIN M, LAJAT Y, RAOUL S, DAMIER P. BILATERAL SUBTHALAMOTOMY THROUGH DBS ELECTRODES: A RESCUE OPTION FOR DEVICE-RELATED INFECTION. NEUROLOGY. 2009;73(15):1243-4. AFTER IMPLANT AND ADJUSTMENT OF THE DBS PARAMETERS AND A PROGRESSIVE REDUCTION OF DRUG TREATMENT, THE PATIENT EXPERIENCED A CLEAR IMPROVEMENT OF SYMPTOMS WITH NO RESIDUAL MOTOR FLUCTUATIONS. THE PATIENT COMPLAINED ONLY OF A MILD DYSARTHRIA. FORTY DAYS AFTER IMPLANT, THE PATIENT WAS READMITTED WITH DELIRIUM AND PYREXIA (39 DEGREES C). CT SCAN REVEALED AN ABSCESS AROUND THE TIP OF THE RIGHT LEAD REQUIRING HARDWARE REMOVAL. DUE TO THE IMPROVEMENT IN THE PATIENT'S SYMPTOMS WITH DBS, THE DOCTOR PRESENTED AND THE PATIENT CONSENTED TO UNDERGO A SUBTHALAMOTOMY. A RADIOFREQUENCY LESION WAS PERFORMED UNDER LOCAL ANESTHESIA THROUGH THE DBS ELECTRODES. THE PROCEDURE WAS SUCCESSFUL AND THE RIGHT LEAD, EXTENSION AND DEVICE WERE REMOVED TWO HOURS LATER. DESPITE ANTIBIOTHERAPY, A SIMILAR INFECTION DEVELOPED FOUR MONTHS LATER AROUND THE LEFT LEAD. FOLLOWING A LEFT SUBTHALAMOTOMY, THE REMAINING SYSTEM COMPONENTS WERE EXPLANTED. THERE WAS A PROGRESSIVE POSITIVE OUTCOME. AT THE THREE-MONTH EXAMINATION, THE PATIENT COMPLAINED OF ONLY MILD, BUT NOT DISABLING INTERMITTENT TREMOR OF THE RIGHT SIDE AND PERSISTING DYSARTHRIA, WHICH HAD NOT WORSENED. THE PATIENT'S "OFF" DRUG STATE WAS SIMILAR TO THAT OBSERVED ONE MONTH AFTER DBS IMPLANT. REFERENCE MFR REPORT #3007566237-2009-09297.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R EXPLANTED:| EXTENSION: MODEL #UNK, LOT #UNK| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL #UNK, LOT #UNK| EXPLANTED:| LEAD: MODEL #UNK, LOT #UNK| EXPLANTED:| IMPLANTED:| SERIAL #UNK| IMPLANTABLE NEUROSTIMULATOR: MODEL #UNK,| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL #UNK, LOT #UNK