BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1943662 · Received December 21, 2010

    Report

    Report Number
    3007566237-2010-10648
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    July 26, 2010
    Report Date
    December 6, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME, NO ADDITIONAL INFORMATION WAS AVAILABLE, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: ACKERMANS L, DUITS A, TEMEL Y, ET AL. LONG-TERM OUTCOME OF THALAMIC DEEP BRAIN STIMULATION IN TWO PATIENTS WITH TOURETTE SYNDROME. J NEUROL NEUROSURG PSYCHIATRY. OCT 2010; 81 (10): 1068-1072. SUMMARY: THE AUTHORS CONDUCTED A FOLLOW-UP STUDY TO REPORT ON THE LONG-TERM (6 AND 10 YEARS) OUTCOME IN TERMS OF TIC REDUCTION, COGNITION, MOOD AND SIDE EFFECTS OF MEDIAL THALAMIC DEEP BRAIN STIMULATION IN TWO PREVIOUSLY DESCRIBED TOURETTE PATIENTS. REPORTABLE EVENT: IN PATIENT 2, ((B)(6) MALE), THE TIC IMPROVEMENT AT 8 MONTHS WAS SLIGHTLY DECREASED AT 6 YEARS; COMPULSIONS HAD DISAPPEARED. THIS PATIENT SHOWED A DECREASE IN VERBAL FLUENCY AND LEARNING, A SLIGHT DECREASE IN DEPRESSION BUT OVERALL PSYCHOPATHOLOGY WAS STILL HIGH AT 6 YEARS WITH AN INCREASE IN ANGER AND AGGRESSION TOGETHER WITH DIFFICULTIES IN SOCIAL ADAPTATION. THIS PATIENT REPORTED A REDUCTION IN ENERGY WHEN THE CURRENT INTENSITY REACHED THE LEVEL NECESSARY FOR AN OPTIMAL EFFECT ON TICS; THIS PATIENT DID NOT ADJUST STIMULATION SETTINGS AND PREFERRED THE FEELING OF DROWSINESS ABOVE HIS TICS. THIS PATIENT DID EXPERIENCE A HARDWARE-RELATED COMPLICATION CONSISTING OF TRACTION OF THE LEAD IN THE NECK. MULTIPLE REVISIONS OF THE WOUND AND LOCAL INJECTIONS WERE CARRIED OUT WITH PARTIAL EFFECT. THIS PATIENT RECEIVED SEVEN REPLACEMENTS IN 6 YEARS DUE TO HIS HIGH-VOLTAGE STIMULATION. THIS PATIENT EXPERIENCED SUBSTANTIAL IMPROVEMENT IN SEXUAL FUNCTIONING AT 8 MONTHS AFTER SURGERY, BUT A SLIGHT DECREASE AT THE LONG-TERM FOLLOW-UP EXCEPT FOR SEXUAL DRIVE THAT INCREASED TO THE MAXIMUM LEVEL. THIS PATIENT EXPERIENCED DIFFICULTY WITH HIS VISUAL ADAPTATION AND VERTIGO, BUT NEITHER OF THESE COMPLAINTS INTERFERED WITH HIS DAILY LIFE. EXAMINATION BY AN OPHTHALMOLOGIST DID NOT REVEAL ANY DISABILITIES. THE ADVERSE EVENTS EXPERIENCES WERE NOT CONSIDERED DISTRESSING AT LONG TERM FOLLOW-UP. SEE LITERATURE ARTICLE WITH MFR REPORT# 3007566237-2010-1064945.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention LEAD: MODEL LEADMVD, LOT# UNKNOWN| EXPLANTED:| LEAD: MODEL LEADMVD, LOT# UNKNOWN| EXPLANTED:| IMPLANTED:| LOT# UNKNOWN| IMPLANTABLE PULSE GENERATOR: MODEL IPGNEURO| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL EXTENSION MVD, LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| IMPLANTED: