BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVA

    MDR report key: 5303015 · Received December 16, 2015

    Report

    Report Number
    3007566237-2015-03881
    Event Type
    Death
    Date Received
    December 16, 2015
    Report Date
    November 30, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. PRODUCT ID: 7428, SERIAL# (B)(4), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 748940, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 338902836, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 748940, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    REUTER, S., DEUSCHL, G., FALK, D., MEHDORN, M., WITT, K. UNCOUPLING OF DOPAMINERGIC AND SUBTHALAMIC STIMULATION: LIFE-THREATENING DBS WITHDRAWAL SYNDROME. MOVEMENT DISORDERS: OFFICIAL JOURNAL OF THE MOVEMENT DISORDER SOCIETY. 2015. DOI: 10.1002/MDS.26324 SUMMARY: DEEP BRAIN STIMULATION (DBS) IN THERAPY FOR ADVANCED PARKINSON¿S DISEASE (PD) IS AN ACCEPTED TREATMENT. INFECTIONS OF THE S YSTEM AND OTHER COMPLICATIONS OCCASIONALLY RESULT IN HARDWARE REMOVAL AND SUBSEQUENT MEDICAL TREATMENT ALONE FOR MONTHS. WE HAVE ANALYZED THE CLINICAL COURSE OF 15 PATIENTS REQUIRING REMOVAL OF AT LEAST PARTS OF THE DBS SYSTEM, RESULTING IN A CESSATION OF STIMULATION. MOST HAD AN UNCOMPLICATED RETURN TO MEDICAL TREATMENT. THREE HAD AN UNFAVORABLE COURSE DURING WITHDRAWAL, INCLUDING TWO DEATHS. THESE PATIENTS HAD SUFFERED FROM PD FOR MORE THAN 18 Y AND HAD HAD DBS FOR MORE THAN 8 Y. WE CONCLUDE THAT DBS WITHDRAWAL CAN BE LIFE-THREATENING, BECAUSE THE WHOLE RANGE OF DOPAMINERGIC AND NONDOPAMINERGIC MEDICAL TREATMENTS MAY BE INEFFECTIVE AT THIS STAGE. THE LACK OF RESPONSE TO MEDICAL TREATMENT MIGHT BE ATTRIBUTABLE TO ADVANCED DISEASE AND LONGTERM CHANGES OF THE BASAL GANGLIA LOOP IN PD. REPORTED EVENTS: [CASE 3, AGE: (B)(6), MALE] IT WAS REPORTED THAT THE PATIENT WAS ADMITTED IN (B)(6) 2014 BECAUSE OF AN ULCEROUS INFECTION OF THE CABLE, ELECTRODES, AND DEEP BRAIN STIMULATION (DBS) IMPLANTABLE NEUROSTIMULATOR (INS). AT THIS TIME, HAVING SUFFERED FROM PARKINSON¿S DISEASE (PD) FOR 19 YEARS, WITH CONTINUOUS DBS FOR 109 MONTHS, HIS UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS)-III SCORE AT ADMISSION WAS 47 POINTS, 700 MG LEDD PLUS 100MG AMANTADINE. IT WAS NOTED THAT THE PATIENT HAD A MEDICAL HISTORY OF BENIGN PROSTATE HYPERPLASIA, SPINAL STENOSIS, AND PERONEAL NERVE INJURY; THE PATIENT WAS INITIALLY IMPLANTED WITH DBS IN (B)(6) 2005, WITH A CHANGE OF THE INS IN (B)(6) 2011. EXPLANTATION OF THE WHOLE SYSTEM WAS PERFORMED THE DAY AFTER ADMISSION, AND ANTIBIOTIC TREATMENT WITH CLINDAMYCIN WAS BEGUN. AN INTRAOPERATIVE SWAB SHOWED NO ANAEROBICS. HARDWARE REMOVAL LED TO A SEVERE LIFE-THREATENING DBS WITHDRAWAL SYNDROME THAT COULD NOT BE CONTROLLED BY DOPAMINERGIC MEDICATION. POSTOPERATIVELY, HE WAS IN A SEVERE AKINETIC STATE WITH EXTREME AXIAL RIGIDITY, DYSARTHRIA, AND DYSPHAGIA, WITH A UPDRS-III SCORE OF 66 POINTS. HE WAS TREATED IN THE INTENSIVE CARE UNIT FOR EIGHT DAYS, WITH POSTOPERATIVE ADMINISTRATION OF A CONTINUOUS SUBCUTANEOUS APOMORPHINE INJECTION BY A PUMP (LEDD: 4800MG) AND 200MG AMANTADINE INTRAVENOUS WITHOUT IMPROVEMENT. HALLUCINATIONS WERE TREATED WITH CLOZAPINE. DESPITE NASOGASTRAL TUBE FEEDING, HE DEVELOPED PNEUMONIA. ANTIBIOTIC TREATMENT WAS CHANGED FROM CLINDAMYCIN/GENTAMYCIN TO CLINDAMYCIN/ CEFTRIAXONE, AND FOUR DAYS LATER TO PIPERACILLIN/TAZOBACTAM. PARAMETERS OF INFLAMMATION WERE DECREASING, BUT THE PATIENT STILL SUFFERED FROM FEVER, AND HE DIED ON (B)(6) 2014, SIXTEEN DAYS AFTER EXPLANTATION. PLEASE NOTE THAT THE EVENT WAS ALSO REPORTED ON THE IMPLANTABLE NEUROSTIMULATOR, ONE LEAD AND ONE EXTENSION IN MANUFACTURING REPORT # 3007566237-2015-02436. THIS NEW REPORT IS A RESULT OF ADDITIONAL DEVICE INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831010 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 338902836

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Death| H| L| R