BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 17618211 · Received August 24, 2023

    Report

    Report Number
    3006630150-2023-05036
    Event Type
    Injury
    Date Received
    August 24, 2023
    Date of Event
    November 29, 2022
    Report Date
    August 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICES COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2208700. MODEL: SC-2208-70. SERIAL: (B)(6). BATCH: 171248/147540.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A NON-FUNCTIONAL SPINAL CORD STIMULATOR (SCS). THE PATIENT UNDERWENT AN SCS EXPLANT PROCEDURE WHERE ALL DEVICE COMPONENT WAS EXPLANTED. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS PER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975343 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 171977

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention