BEUDAMED
    FDA Adverse Event Death Summary report: N

    LOW PROF EXTN INLINE 51CM MVD

    MDR report key: 5289672 · Received December 11, 2015

    Report

    Report Number
    6000153-2015-00469
    Event Type
    Death
    Date Received
    December 11, 2015
    Date of Event
    October 1, 2013
    Report Date
    November 30, 2015
    Manufacturer
    NEURO - VILLALBA
    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. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37601, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 74825136, SERIAL# (B)(4), PRODUCT TYPE EXTENSION. PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# (B)(4), PRODUCT TYPE LEAD. PRODUCT ID 3389028101, SERIAL# (B)(4), PRODUCT TYPE LEAD. (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 SYSTEM 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 2, AGE: (B)(6), MALE] IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MILD LOCAL INFECTION OF THE IMPLANTABLE NEUROSTIMULATOR (INS) IN (B)(6) 2013 AND WAS MANAGED BY ANTIBIOTIC THERAPY. THE PATIENT WAS ADMITTED AGAIN IN (B)(6) 2014 BECAUSE OF SEVERE PURULENT INFECTION OF THE INS AND CABLE. AT THIS TIME, HE HAD SUFFERED FROM PARKINSON¿S DISEASE (PD) FOR 24 YEARS, AND HAD HAD CONTINUOUS DEEP BRAIN STIMULATION (DBS) FOR 124 MONTHS, HIS UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS)-III SCORE AT ADMISSION WAS 38 POINTS, ON 800MG LEDD PLUS 100MG AMANTADINE. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF CONSERVATIVELY TREATED SPINAL STENOSIS AND HAD INITIALLY BEEN IMPLANTED WITH DEEP BRAIN STIMULATION (DBS) IN (B)(6) 2003, WITH CHANGES OF THE INS IN 2009 AND AGAIN IN (B)(6) 2013. IMMEDIATE REMOVAL OF THE INS AND CABLE WAS UNDERTAKEN, AND HE BEGAN ANTIBIOTIC TREATMENT (CLINDAMYCIN/CEFOTAXIME FOR 10 DAYS). AN INTRAOPERATIVE SWAB SHOWED STAPHYLOCOCCUS CAPRAE. HARDWARE REMOVAL LED TO A SEVERE LIFE-THREATENING DBS WITHDRAWAL SYNDROME THAT COULD NOT BE CONTROLLED BY DOPAMINERGIC MEDICATION. STARTING DOPAMINERGIC TREATMENT WITHIN THE FIRST POSTOPERATIVE DAYS, THE PATIENT DEVELOPED A SEVERE AKINETIC STATE, SUFFERING FROM DYSPHAGIA, DYSARTHRIA, AND SEVERE RIGIDITY. WITH INTENSIVE CARE TREATMENT AND BEDRIDDEN DEPENDENCY, HIS UPDRS-III SCORE WAS 94 POINTS. TITRATION LED TO A DOSE OF 2188MG LEDD CONTINUOUSLY ADMINISTERED LEVODOPA (DUODOPA) BY JEJUNAL PUMP PLUS 400MG AMANTADINE. DOPAMINERGIC THERAPY WAS LIMITED BY MEDICALLY UNCONTROLLABLE HALLUCINATIONS. THOUGH HE EXPERIENCED A RECURRENT INFECTION, THE PATIENT SHOWED ONLY SLIGHT IMPROVEMENT OF RIGIDITY AND INTERACTION WITH HIS ENVIRONMENT. HE CONTINUED TO SUFFER FROM DYSPHAGIA WITH INTERMITTENT ASPIRATION, LEADING TO PNEUMONIA TWO WEEKS LATER. ANTIBIOTIC TREATMENT WAS STARTED USING AMPICILLIN/SULBACTAM (FIVE DAYS), AND THEN CHANGED TO MEROPENEM. UNFORTUNATELY, THE PATIENT DIED 50 DAYS AFTER EXPLANTATION ON (B)(6) 2014, BEFORE REIMPLANTATION OF THE INS WAS POSSIBLE. PLEASE NOTE THAT THIS EVENT WAS ALSO REPORTED ON THE IMPLANTABLE NEUROSTIMULATOR AND ONE EXTENSION IN MANUFACTURING REPORT # 3007566237-2015-02433. THIS REPORT IS BEING SUBMITTED DUE TO ADDITIONAL DEVICE INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819849 LOW PROF EXTN INLINE 51CM MVD STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 74825136

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death| H| L| R