BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1022587 · Received April 1, 2008

    Report

    Report Number
    2182207-2008-01722
    Event Type
    Injury
    Date Received
    April 1, 2008
    Report Date
    March 20, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    JOURNAL REFERENCE: ROARK ET AL. "REVERSIBLE NEUROLOGICAL SYMPTOMS CAUSED BY DIATHERMY IN A PATIENT WITH DEEP BRAIN STIMULATORS: CASE REPORT." NEUROSURGERY, 2008 JAN;62 (1):E256; DISCUSSION E256. REPORTABLE EVENT: WE REPORT A CASE OF REVERSIBLE NEUROLOGICAL DEFICIT IN A PATIENT WHO UNDERWENT DIATHERMY 4 YEARS AFTER IMPLANTATION OF BILATERAL DBS LEADS. A MAN WITH WELL-CONTROLLED SYMPTOMS OF PARKINSON'S DISEASE AFTER THE PLACEMENT OF BILATERAL DBS SYSTEM WENT TO HIS PRIMARY CARE PHYSICIAN FOR THE TREATMENT OF RECURRENT NECK PAIN. A COURSE OF DIATHERMY WAS PRESCRIBED, AND AFTER THE SECOND TREATMENT, THE PATIENT DEVELOPED DOUBLE-VISION AND SEVERE RIGHT-SIDED MOTOR CONTRACTIONS. THESE SYMPTOMS RESOLVED WHEN HE TURNED OFF THE IMPLANTED PULSE GENERATORS. THE IPG'S WERE TURNED BACK ON AFTER SEVERAL DAYS, BUT THE SYMPTOMS RECURRED WITHIN 48 HRS. THE VOLTAGES WERE THEREFORE DECREASED, RESULTING IN RESOLUTION OF SYMPTOMS, BUT SUBOPTIMAL CONTROL OF THE PD. A MAGNETIC RESONANCE IMAGING SCAN OF THE BRAIN SHOWED A SMALL AMOUNT OF EDEMA SURROUNDING THE CONTACTS OF THE LEFT-SIDED LEAD. A FOLLOW-UP MRI SCAN 4 WKS LATER DISCLOSED INTERVAL REDUCTION IN THE EDEMA, AND THE PATIENT WAS ABLE TO TOLERATE INCREASED VOLTAGE WITHOUT SYMPTOM RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R STIMULATION LEAD MODEL UNK N=1| IMPLANTABLE STIMULATOR MODEL UNK N=2| EXTENSION MODEL UNK N=2| PROGRAMMER MODEL UNK N=1