BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1617813 · Received February 18, 2010

    Report

    Report Number
    3007566237-2010-01228
    Event Type
    Injury
    Date Received
    February 18, 2010
    Date of Event
    December 31, 2009
    Report Date
    January 27, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    LITERATURE: ORTIZ-PEREZ S, SANCHEZ-DALMAU B, MOLINA J, ADAN A, CANDELA S, RUMIA J. OCULAR TILT REACTION AS A DELAYED COMPLICATION OF DEEP BRAIN STIMULATION FOR PARKINSON'S DISEASE. J NEUROOPTHALMOL, 2009; 29(4):268-8. SUMMARY: THIS ARTICLE PRESENTS A CASE REPORTED OF A PT TREATED WITH BILATERAL DEEP BRAIN STIMULATION (DBS) OF THE SUBTHALAMIC NUCLEI FOR THE TREATMENT OF ADVANCED PARKINSON'S DISEASE. REPORTABLE EVENT: IN THE IMMEDIATE POSTOPERATIVE PERIOD, THE PT DEVELOPED SOMNOLENCE, DISORIENTATION, LEFT HEMIPARESIS, ATAXIA, AND A LEFT BABINSKI REFLEX. CT SHOWED AN INTRACEREBRAL HEMORRHAGE ADJACENT TO THE RIGHT ELECTRODE. THREE WEEKS LATER, THE AREA OF HEMORRHAGE HAD DECREASED, AND ALL CLINICAL DEFICITS HAD RESOLVED. DBS PROVIDED SUBSTANTIAL IMPROVED IN THE PT'S MOTOR SYMPTOMS AND IN THE PT'S ACTIVITIES OF DAILY LIVE. NINE MONTHS AFTER IMPLANT, THE PT SUDDENLY DEVELOPED VERTICAL DIPLOPIA AND HEADACHE. EXAMINATION REVEALED A 20 PRISM-DIOPTER LEFT HYPERTROPIA IN PRIMARY GAZE WITH A RIGHT HEAD TILT. FUNDUS PHOTOGRAPHY SHOWED A LEFT EYE INCYCLOTORSION WITH PERHAPS RIGHT EYE EXCYCLOTORSHION. ON RIGHT GAZE THE HYPERTROPIA WAS 8 PRISM-DIOPTERS, AND ON LEFT GAZE IT WAS 30 PRISM-DIOPTERS. THERE WAS NO MOTOR DEFICIT, SENSORY IMPAIRMENT, ATAXIA, OR CHANGE IN CONSCIOUSNESS. BRAIN CT REVEALED A RIGHT SUBTHALAMIC HEMORRHAGE IN THE SAME PLACE AS THE POSTOPERATIVE HEMORRHAGE. THE OCULAR MOTOR FINDING WERE INTERPRETED AS CONSTITUTING AN IPSIVERSIVE OCULAR TILT REACTION (OTR), INCLUDING OCULAR TORSION TOWARD THE SIDE OF THE LESION AND SKEW DEVIATION. NO INTERVENTION OCCURRED. FOURTEEN MONTHS LATER, THE HEAD TILT AND LEFT HYPERTROPIA HAD SUBSTANTIALLY IMPROVED, BUT THE PT STILL HAD INTERMITTENT DIPLOPIA AND TILT OF THE VISUAL ENVIRONMENT FROM THE OTR.

    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 57 YR Disability EXPLANTED:| EXPLANTED:| EXTENSION: MODEL UNK, LOT# UNK| EXPLANTED:| IMPLANTED:| LEAD: MODEL UNK, LOT# UNK| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL UNK, LOT# UNK| EXTENSION: MODEL UNK, LOT# UNK