BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR FOR DBS

    MDR report key: 5480839 · Received March 4, 2016

    Report

    Report Number
    3007566237-2016-01209
    Event Type
    Injury
    Date Received
    March 4, 2016
    Date of Event
    April 1, 2003
    Report Date
    February 5, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS 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. (B)(4)

    Description of Event or Problem · 1

    UMEMURA, A., JAGGI, J.L., HURTIG, H.I., SIDEROWF, A.D., COLCHER, A., STERN, M.B., BALTUCH, G.H. DEEP BRAIN STIMULATION FOR MOVEMENT DISORDERS: MORBIDITY AND MORTALITY IN 109 PATIENTS. J NEUROSURG. 2003; 98 (4): 779-784. SUMMARY: THERE IS A SIGNIFICANT INCIDENCE OF ADVERSE EVENTS ASSOCIATED WITH THE DEEP BRAIN STIMULATION (DBS) PROCEDURE. NEVERTHELESS, DBS IS CLINICALLY EFFECTIVE IN WELL-SELECTED PATIENTS AND SHOULD BE SERIOUSLY CONSIDERED AS A TREATMENT OPTION FOR PATIENTS WITH MEDICALLY REFRACTORY MOVEMENT DISORDERS. REPORTED EVENTS: A (B)(6) PARKINSON'S DISEASE PATIENT EXPERIENCED "SCALP SKIN EROSION FROM THE DEEP BRAIN STIMULATION (DBS) LEAD WIRE THREE MONTHS AFTER IMPLANTATION." IT WAS NOTED "THERE WAS NO INFECTION" AND THE CONDITION "REQUIRED SURGICAL REPAIR." FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136740 IMPLANTABLE NEUROSTIMULATOR FOR DBS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention