BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3140825 · Received May 31, 2013

    Report

    Report Number
    3007566237-2013-01824
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    October 1, 2011
    Report Date
    October 20, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SEEING HIS NEUROSURGEON.

    Description of Event or Problem · 1

    LOCKSHIN, N. A., LOCKSHIN, B. N. SKIN ULCERATION SECONDARY TO DEEP BRAIN STIMULATION DEVICE LEADS. J AM ACAD DERMATOL. 2011;65(4):E122-123. DOI: 10.1016/J.JAAD.2011.03.025. SUMMARY: WE ARE REPORTING A CASE OF A SKIN ULCERATION OCCURRING AS A LATE COMPLICATION OF DBS. THE PATIENT IS A (B)(6) WHITE MAN WITH A 5-YEAR HISTORY OF PARKINSON DISEASE. BECAUSE OF PROGRESSIVE SYMPTOMS THAT COULD NOT BE ADEQUATELY CONTROLLED WITH MEDICATIONS, HE WAS TREATED WITH DBS. POSTOPERATIVELY, HIS SYMPTOMS WERE ALLEVIATED. APPROXIMATELY 1½ YEARS AFTER HIS SURGERY, A SLOWLY ENLARGING, PAINLESS, CRUSTED PLAQUE ON THE LEFT ANTERIOR PART OF HIS SCALP DEVELOPED. HE WAS REFERRED TO US FOR THE EVALUATION OF THE NON-HEALING SORE. REPORTED EVENT: A PATIENT HAD DEVELOPED A SLOWLY ENLARGING , PAINLESS, CRUSTED PLAQUE ON THE LEFT ANTERIOR PART OF HIS SCALP APPROXIMATELY 1.5 YEARS AFTER SURGERY. ON EXAMINATION, THE PATIENT WAS NOTED TO HAVE A 10-MM CRUSTED AREA ON THE LEFT ANTERIOR SCALP ALONG A LONG, TRANSVERSE, WELL-HEALED SCAR. UPON WIPING THE CRUST WITH AN ALCOHOL SWAB, HE WAS NOTED TO HAVE A DEEP ULCERATION WITH WIRES RUNNING THROUGH THE ULCER THE PATIENT WAS ADVISED TO SEE HIS NEUROSURGEON, WHO EXCISED AND CLOSED THE ULCER BY A ROTATION FLAP. 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
    242025 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention