BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 20906995 · Received December 11, 2024

    Report

    Report Number
    3006630150-2024-08644
    Event Type
    Injury
    Date Received
    December 11, 2024
    Date of Event
    August 22, 2024
    Report Date
    February 11, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729888734
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-ADAPTERS. UPN: M365SC9218150. MODEL: SC-9218-15. SERIAL: (B)(6). BATCH: 7071239. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R-MRI. UPN: M365SC12160. MODEL: SC-1216. SERIAL: (B)(6). BATCH: 503311.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS' MIDLINE INCISION HAD OPENED AND ITS LOOKS LIKE PATIENTS BODY WAS REJECTING THE SPINAL CORD STIMULATOR LEAD. IT WAS NOTED THAT PATIENTS SPINAL CORD STIMULATOR LEAD WAS COMING OUT TO THE SKIN SURFACE. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE WHERE IN ALL DEVICES WERE REMOVED AND WILL NOT BE RETURN AS IT WAS DISCARDED AT THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS MIDLINE INCISION HAD OPENED AND ITS LOOKS LIKE PATIENTS BODY WAS REJECTING THE SPINAL CORD STIMULATOR LEAD. IT WAS NOTED THAT PATIENTS SPINAL CORD STIMULATOR LEAD WAS COMING OUT TO THE SKIN SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718744 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-9218-15 7071199 08714729888734

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention