BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS RC+S

    MDR report key: 12198167 · Received July 20, 2021

    Report

    Report Number
    2182207-2021-01275
    Event Type
    Injury
    Date Received
    July 20, 2021
    Date of Event
    May 28, 2021
    Report Date
    July 20, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_BURRHOLECAP, LOT# UNKNOWN, IMPLANTED: (B)(6) 2020, PRODUCT TYPE: ACCESSORY. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_BURRHOLECAP, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S INCISION SITE WAS SHOWING SCALP EROSION 15 MONTHS AFTER IMPLANT. THE PATIENT WAS TREATED WITH DEBRIMENT AND REMOVAL OF THE BURR HOLE CAP. THE LEAD REMAINED IN PLACE. AGGRESSIVE ANTIBIOTICS WERE ADMINISTERED, AND INVESTIGATION INTO IF INFECTION WAS PRESENT WAS PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED THAT WHEN THE EVENT WAS FIRST OBSERVED, THE NEUROLOGIST NOTED A 0.5CM DIAMETER BLACK SCALY RAISED LESION ON LEFT SCALP ADJACENT TO BUT NOT OVERLYING HIS DBS BURR HOLE CAP¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092321 OLYMPUS RC+S STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION B35300R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention