BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN NEUROSTIMULATION DEVICE

    MDR report key: 3024106 · Received March 27, 2013

    Report

    Report Number
    3007566237-2013-00906
    Event Type
    Death
    Date Received
    March 27, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IS AN AVERAGE FOR ALL THE PATIENTS. 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, LOT# 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, LOT# SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, LOT# SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, LOT# SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_INS_STIMULATOR LOT# SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR LOT# SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR LOT# SERIAL# UNKNOWN PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR LOT# SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, LOT# SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR LOT# SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, LOT# SERIAL# UNKNOWN PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR LOT# SERIAL# UNKNOWN PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR LOT# SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR LOT# SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR LOT# SERIAL# UNKNOWN PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR LOT# SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR LOT# SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3389 LOT# SERIAL# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    SCHUEPBACH WM, RAU J, KNUDSEN K, VOLKMANN, J., KRACK, P., TIMMERMANN, L., HALBIG, T. D., HESEKAMP, H., NAVARRO, S. M., MEIER, N., FALK, D., MEHDORN, M., PASCHEN, S., MAAROUF, M., BARBE, M. T., FINK, G. R., KUPSH, A., GRUBER, D., SCHNEIDER G.-H., SEIGNEURET, E., KISTNER, A., CHAYNES, P., ORY-MAGNE, F., BREFEL COURBON, C., VESPER, J., SCHNITZLER, A., WOJTECKI, L., HOUETO, J.-L., BATAILLE, B., MALTETE, D., DAMIER, P., RAOUL, S., SIXEL-DOERING, F., HELLWIG, D., MERTENS, P., KLOSS, M., HARTMANN, A., OERTEL, W. H., POST, B., SPEELMAN, H., AGID, Y., SCHADE-BRITTINGER, C., DEUSCHL, G. NEUROSTIMULATION FOR PARKINSON'S DISEASE WITH EARLY MOTOR COMPLICATIONS. THE NEW ENGLAND JOURNAL OF MEDICINE. 2013;368(7):610-622. 10.1056/NEJMOA1205158. SUMMARY: IN THIS 2-YEAR TRIAL, WE RANDOMLY ASSIGNED 251 PATIENTS WITH PARKINSON'S DISEASE AND EARLY MOTOR COMPLICATIONS (MEAN AGE, 52 YEARS; MEAN DURATION OF DISEASE, 7.5 YEARS) TO UNDERGO NEUROSTIMULATION PLUS MEDICAL THERAPY OR MEDICAL THERAPY ALONE. THE PRIMARY END POINT WAS QUALITY OF LIFE, AS ASSESSED WITH THE USE OF THE PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39) SUMMARY INDEX (WITH SCORES RANGING FROM 0 TO 100 AND HIGHER SCORES INDICATING WORSE FUNCTION). MAJOR SECONDARY OUTCOMES INCLUDED PARKINSONIAN MOTOR DISABILITY, ACTIVITIES OF DAILY LIVING, LEVODOPA-INDUCED MOTOR COMPLICATIONS (AS ASSESSED WITH THE USE OF THE UNIFIED PARKINSON'S DISEASE RATING SCALE, PARTS III, II, AND IV, RESPECTIVELY), AND TIME WITH GOOD MOBILITY AND NO DYSKINESIA. REPORTED EVENTS: 1. 2 PATIENTS COMMITTED SUICIDE. 2. 14 LIFE THREATENING EVENTS OCCURRED. 3. 5 PATIENTS EXPERIENCED SEVERE WORSENING OF MOBILITY REQUIRING HOSPITALIZATION. 4. 1 PATIENT EXPERIENCED SEVERE DYSKINESIA REQUIRING HOSPITALIZATION. 5. 1 PATIENT EXPERIENCED SEVERE IMPULSE CONTROL DISORDER REQUIRING HOSPITALIZATION. 6. 6 PATIENTS EXPERIENCED SEVERE DEPRESSION REQUIRING HOSPITALIZATION. 7. 1 PATIENT HAD SUICIDAL IDEATIONS. 8. 2 PATIENTS ATTEMPTED SUICIDE. 9. 3 PATIENTS EXPERIENCED SERIOUS INJURY RELATED TO THE MEDICATION OR STIMULATION. 10. 1 PATIENT EXPERIENCED SERIOUS RESPIRATORY ORTHORACIC DISORDER. 11. 4 PATIENTS EXPERIENCED OTHER SERIOUS ADVERSE EVENTS RELATED TO MEDICATION OR STIMULATION. 12. 3 PATIENTS EXPERIENCED IMPAIRED WOUND HEALING. THE PATIENTS COMPLETELY RECOVERED. 13. 1 PATIENT EXPERIENCED IMPAIRED WOUND HEALING, WHICH RESULTED IN MILD SCARRING. 14. 2 PATIENTS EXPERIENCED INTRACEREBRAL ABSCESS OR EDEMA. THE SYMPTOMS COMPLETELY RESOLVED. 15. 5 EVENTS OF DEVICE DISLOCATION WERE REPORTED. ALL THE PATIENTS COMPLETELY RECOVERED. 16. 4 REOPERATIONS OCCURRED TO REPAIR THE STIMULATOR OR LEAD. ALL THE PATIENTS COMPLETELY RECOVERED. 17. 11 OTHER EVENTS RELATED TO THE SURGERY OR DEVICES WERE REPORTED. ALL THE PATIENTS COMPLETELY RECOVERED. 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
    127069 UNKNOWN NEUROSTIMULATION DEVICE STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Death| L| R