BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3043986 · Received April 9, 2013

    Report

    Report Number
    3007566237-2013-01164
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. PRODUCT ID NEU_INS_STIMULATOR, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID NEU_INS_STIMULATOR, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID NEU_UNKNOWN_EXT, SERIAL # UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL # UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL # UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL # UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_INS_STIMULATOR, LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL # UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    LAURENT, V., VAN DEN MUNCKHOF, P., CONTARINO, M. F., VAN DER VEER, O., VELSEBOER, D. C., SCHOLTEN, M. N., SCHUURMAN, P. R., DE BIE,R. M. A. PATIENT PERCEPTION OF DEEP BRAIN STIMULATION HARDWARE. MOVEMENT DISORDERS. (B)(4). SUMMARY: A SURVEY AMONG A LARGE COHORT OF DBS PATIENTS IN WHICH THEY REPORTED THEIR PERCEPTION OF THE IMPLANTED MATERIALS. IN ADDITION, THEY INVESTIGATED POSSIBLE INFLUENCING FACTORS ON THE FREQUENCY OF HARDWARE RELATED COMPLAINTS SUCH AS PATIENT- AND HARDWARE CHARACTERISTICS. A SURVEY WAS CONDUCTED AMONG 298 PATIENTS OPERATED ON BETWEEN 1993 AND 2009 TO EVALUATE THEIR PERCEPTION OF THE IPG AND EXTENSION CABLES CONNECTED TO THE ELECTRODES. THEY DID NOT SEND A QUESTIONNAIRE TO THE REMAINING 60 PATIENTS WHO WERE OPERATED ON IN THE SAME PERIOD FOR THE FOLLOWING REASONS: DECEASED, LIVING ABROAD, DBS SYSTEM EXPLANTATION AND PROCEDURE ABORTION. IN TOTAL, 173 PATIENTS (RESPONDERS; 58%) COMPLETED THE QUESTIONNAIRE (61 WOMEN; MEAN AGE, 58.3 YEARS, SD, 11.0 YEARS). SEVENTY-SIX PERCENT OF THE RESPONDERS HAD PARKINSON'S DISEASE, 13% DYSTONIA, AND 12% TREMOR. THE MEAN TIME BETWEEN THE FIRST SURGERY AND THE QUESTIONNAIRE WAS 5.5 YEARS (RANGE, 1-17 YEARS). RESPONDERS HAD A HIGHER MEAN AGE AND MORE OFTEN HAD PARKINSON'S DISEASE THAN THE NON-RESPONDERS. REPORTED EVENT: 6 PATIENTS HAD ADDITIONAL SURGERY BECAUSE OF PAIN AND DISCOMFORT FROM THE HARDWARE. 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
    146804 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention