BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3423347 · Received October 22, 2013

    Report

    Report Number
    3007566237-2013-03430
    Event Type
    Injury
    Date Received
    October 22, 2013
    Date of Event
    July 9, 2013
    Report Date
    October 8, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. THE DEVICES WERE USED FOR MULTIPLE INDICATIONS. PRODUCT ID: 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    CONTARINO, M. F., BOT, M., SPEELMAN, J. D., ET AL.DE BIE, R. M., TIJSSEN, M. A., DENYS, D., BOUR, L. J., SCHUURMAN, R., MUNCKHOF, P. POSTOPERATIVE DISPLACEMENT OF DEEP BRAIN STIMULATION ELECTRODES RELATED TO LEAD-ANCHORING TECHNIQUE. NEUROSURGERY. 2013;73(4):681-688. DOI: 10.1227/NEU.0000000000000079. SUMMARY: DISPLACEMENT OF DEEP BRAIN STIMULATION (DBS) ELECTRODES MAY OCCUR AFTER SURGERY, ESPECIALLY DUE TO LARGE SUBDURAL AIR COLLECTIONS, BUT OTHER FACTORS MIGHT CONTRIBUTE. TO INVESTIGATE FACTORS POTENTIALLY CONTRIBUTING TO POSTOPERATIVE ELECTRODE DISPLACEMENT, IN PARTICULAR, DIFFERENT LEAD-ANCHORING TECHNIQUES. WE RETROSPECTIVELY ANALYZED 55 PATIENTS (106 ELECTRODES) WITH PARKINSON DISEASE, DYSTONIA, TREMOR, AND OBSESSIVE-COMPULSIVE DISORDER IN WHOM EARLY POSTOPERATIVE AND LONG-TERM FOLLOW-UP COMPUTED TOMOGRAPHY (CT) WAS PERFORMED. ELECTRODES WERE ANCHORED WITH A TITANIUM MICROPLATE OR WITH A COMMERCIALLY AVAILABLE PLASTIC CAP SYSTEM. TWO INDEPENDENT EXAMINERS DETERMINED THE STEREOTACTIC COORDINATES OF THE DEEPEST DBS CONTACT ON EARLY POSTOPERATIVE AND LONG-TERM FOLLOW-UP CT. THE INFLUENCE OF AGE, SURGERY DURATION, SUBDURAL AIR VOLUME, USE OF MICRORECORDINGS, FIXATION METHOD, FOLLOW-UP TIME, AND SIDE OPERATED ON FIRST WAS ASSESSED. SUBDURAL AIR COLLECTIONS MEASURED ON AVERAGE 4.36 6.2 CM3. THREE-DIMENSIONAL (3-D) ELECTRODE DISPLACEMENT AND DISPLACEMENT IN THE X, Y, AND Z AXES SIGNIFICANTLY CORRELATED ONLY WITH THE ANCHORING METHOD, WITH LARGER DISPLACEMENT FOR MICROPLATE-ANCHORED ELECTRODES. THE AVERAGE 3-D DISPLACEMENT FOR MICROPLATE-ANCHORED ELECTRODES WAS 2.3 6 2.0 MM VS 1.5 6 0.6 MM FOR ELECTRODES ANCHORED WITH THE PLASTIC CAP (P = .030). FIFTY PERCENT OF THE MICROPLATE-ANCHORED ELECTRODES SHOWED 2-MM OR GREATER (POTENTIALLY RELEVANT) 3-D DISPLACEMENT VS ONLY 25% OF THE PLASTIC CAP¿ANCHORED ELECTRODES (P , .01). THE COMMERCIALLY AVAILABLE PLASTIC CA P SYSTEM IS MORE EFFICIENT IN PREVENTING POSTOPERATIVE DBS ELECTRODE DISPLACEMENT THAN TITANIUM MICROPLATES. A RELIABILITY ANALYSIS OF THE ELECTRODE FIXATION IS WARRANTED WHEN ALTERNATIVE ANCHORING METHODS ARE USED. REPORTED EVENTS: 1. ONE PATIENT WITH BILATERAL IMPLANTATION HAD ONE ELECTRODE EXPLANTED EARLY AFTER IMPLANTATION DUE TO INFECTION. 2. ONE PATIENT WITH CERVICAL DYSTONIA PRESENTED WITH A LACK OF EFFECT. IT WAS NOTED THAT THE LEAD HAD MIGRATED 14.7MM UPWARD AND HAD TO BE REPOSITIONED. IT WAS NOTED THAT THE LEAD HAD BEEN ANCHORED USING A CUSTOM-MADE TITANIUM MICROPLATE. 3. 55 DEEP BRAIN STIMULATION (DBS) PATIENTS EXPERIENCED ELECTRODE DISPLACEMENT. THE AVERAGE DISPLACEMENT OF ELECTRODES ANCHORED WITH THE CUSTOM-MADE TITANIUM MICROPLATE WAS 2.3MM ALONG THE ELECTRODE TRAJECTORY; IT WAS NOTED THAT 24 OF THESE ELECTRODES SHOWED A DISPLACEMENT OF 2MM OR GREATER. THE AVERAGE DISPLACEMENT OF ELECTRODES ANCHORED WITH THE COMMERCIALLY AVAILABLE PLASTIC CAP ANCHORING SYSTEM WAS 1.5MM ALONG THE ELECTRODE TRAJECTORY; IT WAS NOTED THAT 14 OF THESE ELECTRODES SHOWED A DISPLACEMENT OF 2MM OR GREATER. 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
    539943 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention