BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLIK X

    MDR report key: 12705512 · Received October 27, 2021

    Report

    Report Number
    3006630150-2021-06024
    Event Type
    Injury
    Date Received
    October 27, 2021
    Date of Event
    March 14, 2021
    Report Date
    October 27, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905318
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R: UPN: M365SC11600, MODEL: SC-1160, SERIAL: (B)(4), BATCH/LOT: 348649. PRODUCT FAMILY: SCS-PADDLE LEADS: UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(4), BATCH/LOT: 7042218.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS LEAD ERODED THROUGH THE SKIN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS PLACED WITH ANTIBIOTICS. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED DEVICES WERE DISPOSED BY FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603248 CLIK X STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-4318 23058787 08714729905318

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention