BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 18460613 · Received January 5, 2024

    Report

    Report Number
    3006630150-2023-08489
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    July 4, 2023
    Report Date
    January 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138250, MODEL: SC-3138-25, SERIAL: (B)(6), BATCH: 7030242/7030162.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BOWEL OBSTRUCTION, LEG WEAKNESS, AND PAIN. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REVISION PROCEDURE WHEREIN THE PATIENTS IPG WAS REPLACED AND LEAD EXTENSIONS WERE REMOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WERE DISPOSED BY THE FACILITY AND THEREFORE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620642 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 340495 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention