BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 20539089 · Received October 25, 2024

    Report

    Report Number
    3006630150-2024-07346
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    October 10, 2024
    Report Date
    October 25, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729760559
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138350, MODEL: SC-3138-35, SERIAL: (B)(6), BATCH: 7072654. PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138350, MODEL: SC-3138-35, SERIAL: (B)(6), BATCH: 7072825. PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138350, MODEL: SC-3138-35, SERIAL: (B)(6), BATCH: 7075061.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED DUE TO LEADS WERE CAUSING THE PATIENT IRRITATION. THE PATIENT IS DOING WELL POST OPERATIVELY, THE LOCATION OF THE DEVICE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048612 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-3138-35 7072599 08714729760559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention