BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2802640 · Received October 24, 2012

    Report

    Report Number
    3007566237-2012-02499
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 27, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MFR
    PMA / PMN Number
    H050003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    LITERATURE: SACHDEV, P. S., CANNON, E., COYNE, T. J., SILBURN, P. BILATERAL DEEP BRAIN STIMULATION OF THE NUCLEUS ACCUMBENS FOR COMORBID OBSESSIVE COMPULSIVE DISORDER AND TOURETTE'S SYNDROME. BMJ CASE REPORTS 2012;10.1136/BCR-2012-006579, PUBLISHED SEPTEMBER 13, 2012. SUMMARY: WE PRESENT THE CASE OF A 32-YEAR-OLD CAUCASIAN WOMAN WITH SEVERE TREATMENT-REFRACTORY OBSESSIVE COMPULSIVE DISORDER (OCD) AND TOURETTE'S SYNDROME. BOTH CONDITIONS WERE PRESENT PRIOR TO AGE 5 AND IMPACTED SIGNIFICANTLY ON THE PATIENT'S FUNCTIONING. MULTIPLE TRIALS OF EVIDENCE-BASED PHARMACOLOGICAL AND BEHAVIOURAL THERAPIES HAD NOT ACHIEVED REMISSION OF SYMPTOMS. BILATERAL DEEP BRAIN STIMULATION OF THE NUCLEUS ACCUMBENS WAS UNDERTAKEN TO TREAT BOTH ILLNESSES BUT WITH A PARTICULAR FOCUS ON OCD, AS THE PATIENT IDENTIFIED THIS AS THE MORE DEBILITATING OF THE TWO DISORDERS. FOLLOWING SURGERY THERE WAS AN IMMEDIATE IMPROVEMENT IN OCD AND TIC SEVERITY. AT FOLLOW-UP 8 MONTHS LATER, THERE WAS A 90% IMPROVEMENT IN OCD SYMPTOMS AND A 57% IMPROVEMENT IN TIC SEVERITY. NO INTRAOPERATIVE OR POSTOPERATIVE COMPLICATIONS OR ADVERSE EVENTS OCCURRED AND THERE WERE NO UNDESIRED EFFECTS OF STIMULATION. REPORTED EVENT: ON ONE OCCASION THE PATIENT ACCIDENTLY SWITCHED OFF THE DEVICE FOR 5 DAYS AND DURING THIS TIME THE OCD SYMPTOMS RETURNED TO BASELINE. ONCE THE DEVICE WAS TURNED ON AGAIN, THE OCD SYMPTOMS IMPROVED WITHIN 48 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MFR MEDTRONIC NEUROMODULATION 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR