BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1943663 · Received December 21, 2010

    Report

    Report Number
    3007566237-2010-10649
    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): (DECREASE IN ERECTILE AND ORGASMIC FUNCTION). 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 1, ((B)(6) MALE), TIC IMPROVEMENTS WERE OBSERVED AT 5 YEARS AND WERE MAINTAINED AT 10 YEARS; COMPULSIONS HAD DISAPPEARED. THIS PATIENT REVEALED NO CHANGES IN COGNITION DURING FOLLOW-UP. THIS PATIENT REPORTED A REDUCTION IN ENERGY WHEN THE CURRENT INTENSITY REACHED THE LEVEL NECESSARY FOR AN OPTIMAL EFFECT ON TICS THEREFORE, THEY TURNED DOWN STIMULATION A FEW TIMES DURING THE DAY. 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 TWO IPG REPLACEMENTS IN 10 YEARS. AT LONG-TERM FOLLOW-UP, THERE WAS A DECREASE IN ERECTILE AND ORGASMIC FUNCTION OF THIS PATIENT WHEN COMPARED WITH SCORES BEFORE AND 5 YEARS AFTER SURGERY. THIS PATIENT APPEARED TO HAVE DIFFICULTY DRIVING HIS CAR WITH THE STIMULATOR ON, BECAUSE OF A SO-CALLED BLURRED VISION WHEN LOOKING AHEAD. TURNING DOWN THE VOLTAGE BY HIS PATIENT PROGRAMMER REDUCED THESE COMPLAINTS. THE ADVERSE EVENTS EXPERIENCED WERE NOT CONSIDERED DISTRESSING AT LONG-TERM FOLLOW-UP.

    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 42 YR Required Intervention EXPLANTED:| EXPLANTED:| LOT# UNKNOWN| IMPLANTABLE PULSE GENERATOR: MODEL IPGNEURO,| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL EXTENSION MVD, LOT# UNKNOWN| EXTENSION: MODEL EXTENSION MVD, LOT# UNKNOWN| LEAD: MODEL LEADMVD, LOT# UNKNOWN| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL LEADMVD, LOT# UNKNOWN