BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 21395136 · Received February 18, 2025

    Report

    Report Number
    3006630150-2025-00782
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    May 16, 2024
    Report Date
    February 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2317500; MODEL: SC-2317-50; SERIAL: (B)(6); BATCH: 7070022/7072778.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED PAIN OR PRESSURE AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE AND HAD INADEQUATE PAIN RELIEF FROM THE SPINAL CORD STIMULATOR (SCS) DEVICE THE PATIENT UNDERWENT AN SCS SYSTEM EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205835 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 372502 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention