BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6337194 · Received February 16, 2017

    Report

    Report Number
    3007566237-2017-00699
    Event Type
    Injury
    Date Received
    February 16, 2017
    Date of Event
    December 13, 2016
    Report Date
    February 16, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387, PRODUCT TYPE: LEAD. PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    OERTEL MF, SCHUPBACH WMM, GHIKA JA, STIEGLITZ LH, FIECHTER M, KAELIN-LANG A, RAABE A, POLLO C. COMBINED THALAMIC AND SUBTHALAMIC DEEP BRAIN STIMULATION FOR TREMOR-DOMINANT PARKINSON¿S DISEASE. ACTA NEUROCHIR. 2016. DOI: 10.1007/S00701-016-3044-5. SUMMARY: DEEP BRAIN STIMULATION (DBS) IN THE THALAMIC VENTRAL INTERMEDIATE (VIM) OR THE SUBTHALAMIC NUCLEUS (STN) REPORTEDLY IMPROVES MEDICATION-REFRACTORY PARKINSON¿S DISEASE (PD) TREMOR. HOWEVER, LITTLE IS KNOWN ABOUT THE POTENTIAL SYNERGIC EFFECTS OF COMBINED VIM AND STN DBS. WE DESCRIBE A (B)(6) MAN WITH MEDICATION-REFRACTORY TREMOR-DOMINANT PD. BILATERAL VIM DBS ELECTRODE IMPLANTATION PRODUCED INSUFFICIENT IMPROVEMENT. THEREFORE, THE PATIENT UNDERWENT ADDITIONAL UNILATERAL LEFT-SIDED STN DBS. WHEREAS VIM OR STN STIMULATION ALONE LED TO PARTIAL IMPROVEMENT, PERSISTING TREMOR RESOLUTION OCCURRED AFTER SIMULTANEOUS STIMULATION. THE COMBINATION OF BOTH TARGETS MAY HAVE A SYNERGIC EFFECT AND IS AN ALTERNATIVE OPTION IN SUITABLE CASES. REPORTED EVENT: ONE (B)(6) MALE PATIENT WITH AN11-YEAR HISTORY OF TREMOR-DOMINANT PARKINSON¿S DISEASE (PD) RECEIVED BILATERAL THALAMIC VENTRAL INTERMEDIATE (VIM) DEEP BRAIN STIMULATION (DBS); TWO YEARS AFTER IMPLANT, THE PATIENT PRESENTED TO A DIFFERENT INSTITUTION DUE TO PERSISTENT DISABLING TREMOR. POSTOPERATIVELY, HE EXHIBITED A PERSISTING RIGHT-SIDED TREMOR, WHICH WORSENED WITH TIME. STIMULATION WITH HIGHER AMPLITUDES LED TO INTRACTABLE SIDE EFFECTS, INCLUDING DYSARTHRIA AND GAIT DISTURBANCE. CLINICAL EXAMINATION SHOWED BRADYKIN ESIA, RIGIDITY, COGNITIVE IMPAIRMENT AND A SIGNIFICANT BILATERAL RESTING TREMOR, PARTIALLY IMPROVED ON BOTH SIDES UNDER BILATERAL VIM STIMULATION, ALTHOUGH STILL DISABLING ON THE RIGHT SIDE. EXTERNAL POSTOPERATIVE 1.5T MAGNETIC RESONANCE IMAGING (MRI) REVEALED SUBOPTIMAL IMPLANTATION OF THE LEFT-SIDED LEAD AND CALCULATION OF THE COORDINATES OF THE STIMULATING ELECTRODES RELATED TO THE MID-COMMISSURAL POINT (MCP) DEMONSTRATED MEDIAL AND POSTERIOR DISPLACEMENT COMPARED WITH CONVENTIONAL ATLAS-BASED COORDINATES. OWING TO THE INSUFFICIENT STIMULATION EFFECT AND BECAUSE THE RESIDUAL SYMPTOMS INCREASINGLY INTERFERED WITH HIS DAILY LIFE, AND DID NOT RESPOND WELL TO MEDICATION, THE PATIENT UNDERWENT ADDITIONAL UNILATERAL DBS. BECAUSE OF THE PARTIAL EFFECT OF STIMULATION WITH THE PREVIOUSLY IMPLANTED LEFT VIM ELECTRODE AND THE POTENTIAL FOR BLEEDING IF REMOVED, THE IMPLANTED ELECTRODE WAS LEFT IN PLACE. MOREOVER, DUE TO POSSIBLE GLIOSIS AROUND THIS ELECTRODE, WHICH COULD PREVENT AN OPTIMAL DBS EFFECT THROUGH A NEWLY IMPLANTED LEAD IN ITS VICINITY, AND THE PRESENCE OF SLIGHT BRADYKINESIA AND RIGIDITY, A SUBSEQUENT IMPLANTATION IN THE LEFT SUBTHALAMIC NUCLEUS (STN) WAS PREFERRED. DIRECT POSTOPERATIVE STEREOTACTIC CT WAS PERFORMED AND CO-REGISTERED WITH THE PREOPERATIVE IMAGING TO CONFIRM THE NEWLY IMPLANTED LEAD¿S LOCATION. IN ADDITION TO THE PREVIOUSLY IMPLANTED RIGHT-SIDED SINGLE-CHANNEL IMPLANTABLE NEUROSTIMULATOR (INS), A DUAL-CHANNEL PRIMARY CELL INS WAS PLACED IN THE LEFT INFRACLAVICULAR REGION AND CONNECTED TO BOTH THE VIM AND STN LEAD UNDER GENERAL ANESTHESIA. MONOPOLAR STIMULATION WAS PERFORMED ON THE TWO VENTRAL CONTACTS OF THE LEFT VIM LEAD, WHILE BIPOLAR STIMULATION WAS APPLIED ON THE TWO MIDDLE CONTACTS OF THE LEFT STN ELECTRODE. POSTOPERATIVELY, THE PATIENT WAS ASSESSED WITH COMBINED VIM AND STN STIMULATION ON USUAL 400MG DAILY LEVODOPA. OFF STIMULATION WAS NOT TOLERATED DUE TO UNBEARABLE GENERALIZED TREMOR (REBOUND EFFECT) WITH 5CM AMPLITUDE TREMOR OF ALL FOUR EXTREMITIES AND CHIN. ISOLATED DBS OF THE LEFT-SIDED STN OF DIFFERENT AND VARYING STIMULATION PARAMETERS NOT ONLY LED TO AN INTRACTABLE REBOUND EFFECT, BUT WAS ALSO UNABLE TO SUFFICIENTLY SUPPRESS THE SYMPTOMS AND WAS THEREFORE RAPIDLY DISCONTINUED. IT WAS NOTED THAT WHEREAS VIM AND STN STIMULATION ALONE LED TO PARTIAL IMPROVEMENT, PERSISTING TREMOR RESOLUTION OCCURRED AFTER SIMULTANEOUS STIMULATION. THE AUTHORS STATED THAT ALTHOUGH A PARTIAL EFFECT OF VIM DBS PERSISTED, THE LEFT VIM ELECTRODE HAD BEEN SUBOPTIMALLY PLACED RESULTING IN AN INCOMPLETE VIM STIMULATION EFFECT, AND RE-IMPLANTATION APPEARED TO LEAD TO FURTHER IMPROVEMENT OF CLINICAL OUTCOME. ALTHOUGH ULTIMATELY, THE EXACT COMPLEMENTARY EFFECT OF DUAL STIMULATION WAS NOT COMPLETELY CLEAR, A SYNERGIC EFFECT WAS OBTAINED THROUGH SIMULTANEOUS VIM AND STN STIMULATION. HOWEVER, DUE TO THE SUBOPTIMAL LOCATION OF THE VIM ELECTRODE, IT WAS UNLIKELY THAT THE VTA REACHED THE OPTIMAL VIM TARGET VIA THE THALAMIC ELECTRODE. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: LEAD MODEL 3387; LEAD MODEL 3389; IMPLANTABLE NEUROSTIMULATOR ACTIVA SC (NO MODEL NUMBER PROVIDED); IMPLANTABLE NEUROSTIMULATOR ACTIVA PC MODEL 37601.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119600 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention