BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3358064 · Received September 19, 2013

    Report

    Report Number
    3007566237-2013-03074
    Event Type
    Malfunction
    Date Received
    September 19, 2013
    Date of Event
    April 1, 2012
    Report Date
    August 20, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT PRODUCT: PRODUCT ID 3387, LOT# UNKNOWN, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    PATEL, N., SHAHED, J. J. ET AL. SIMULTANEOUS IMPROVEMENT OF TICS AND DRUG-INDUCED PARKINSONISM AFTER GLOBUS PALLIDUS PARS INTERNA DEEP BRAIN STIMULATION (GPI DBS): A CASE REPORT. NEUROLOGY 80: ABSTR. IN11. 2013. SUMMARY/REPORTED EVENT: THE AUTHOR DESCRIBES ABOUT THE CASE REPORT OF SIMULTANEOUS IMPROVEMENT OF TICS AND DRUG-INDUCED PARKINSONISM AFTER GLOBUS PALLIDUS PARS INTERNA DEEP BRAIN STIMULATION (GPI DBS). THIS CASE REFERS TO A CASE OF (B)(6) FEMALE PATIENT. THE PATIENT WAS FIRSTLY EVALUATED TS (TOURETTE SYNDROME) AT THE AGE OF 14. THE PATIENT WAS ON MULTIPLE MEDICATIONS OF UNKNOWN MANUFACTURER USED IN COMBINATION INCLUDED TETRABENAZINE 150MG/ DAY, FLUPHENAZINE 3MG PER DAY, TOPIRAMATE 225MG/DAY, CLONIDINE AND GUANFACINE, BACLOFEN, METAXALONE, BENZODIAZEPINES, METHYLPHENIDATE, MULTIPLE SEROTONIN REUPTAKE INHIBITORS, BOTULINUM TOXIN INJECTIONS TO VOCAL CORDS FOR COPROLALIA. THE PATIENT WAS REFRACTORY TO THE THERAPIES. SHE HAD SELF-INJURIOUS MOTOR TICS (WHIPLASH TICS, ARM FLAILING, AND LEG EXTENSION, PUNCHING AND KICKING WALLS, SELF-CUTTING. VOCAL TICS: PARTIAL WORD REPETITION, LOUD SOUNDS AND COPROLALIA. OBSESSIVE COMPULSIVE BEHAVIORS (OCB), ATTENTION DEFICIT AND HYPERACTIVITY DISORDER (ADHD), DEPRESSION. SYMPTOMS WERE COMPLICATED BY MILD, NON-IMPAIRING PARKINSONISM (SUBTLE BRADYKINESIA AND RIGIDITY). THE PRE-OPERATIVE MEDICATIONS INCLUDED: TETRABENAZINE 112.5MG/DAY, ARIPIPRAZOLE 4MG/DAY AND FLUPHENAZINE 3MG/DAY. AFTER CONSENSUS REVIEW THE PATIENT UNDERWENT BILATERAL GPI DBS (3387 LEADS, ACTIVA PC PULSE GENERATOR, MEDTRONIC, MINNEAPOLIS, MN) IN FEBRUARY 2011. PRE-OPERATIVE YGTSS WAS 89 (39 SEVERITY; 50 IMPAIRMENT). AT 6MONTH FOLLOW-UP WITH STIMULATION THERE WAS REDUCTION IN YGTSS SCORES. THE NEUROLEPTIC MEDICATIONS WERE REDUCED TO ARIPIPRAZOLE (UNKNOWN MANUFACTURER) AT A DOSE OF 5 MG PER DAY AND TETRABENAZINE (UNKNOWN MANUFACTURER) AT A DOSE OF 64.5 MG PER DAY FOR TOURETTE'S SYNDROME (SEE CASE: (B)(6)). THE AUTHOR DEMONSTRATES SIMULTANEOUS IMPROVEMENT IN HYPERKINETIC (TIC) AND HYPOKINETIC (PARKINSONIAN) MOVEMENTS WITH GPI STIMULATION. THIS WAS THE FIRST CASE OF DIP REPORTED TO IMPROVE WITH BILATERAL GPI DBS, THOUGH MEDICATION ADJUSTMENT WAS THE TREATMENT OF CHOICE IN TYPICAL CASES OF DIP. THE OUTCOME OF REFRACTORY TO THERAPIES WAS AN UNKNOWN. SERIOUSNESS OF EVENTS WAS NOT REPORTED. CAUSALITY OF EVENT WAS ASSESSED AS SUSPECTED WITH RELATION TO MULTIPLE SUSPECTED MEDICATIONS. REPORTED EVENT: 14 MONTHS AFTER IMPLANTATION, SHE EXPERIENCED SHOCK-LIKE PAIN OVER HER ABDOMINAL PULSE GENERATOR AND WAS ADVISED TO DISCONTINUE STIMULATION DUE TO CONCERN FOR HARDWARE MALFUNCTION. 6 DAYS AFTER DISCONTINUATION OF STIMULATION, EXAMINATION REVEALED MARKED PARKINSONISM WITH EXACERBATION OF COMPLEX MOTOR AND VOCAL TICS (CLAPPING, HEAD JERKING, LEG EXTENSION, HITTING HEAD WITH FIST, COPROLALIA AND OTHER SOUNDS. PARKINSONISM GRADUALLY IMPROVED WITH AMPLITUDE RE-TITRATION OF FINAL SETTINGS OF 5.5V BILATERALLY. IN THE FOLLOWING DAYS, A HERPES ZOSTER RASH OVERLYING BATTERY SIDE EMERGED, EXPLAINING HER PAIN. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472754 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00021 YR