BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 21349893 · Received February 10, 2025

    Report

    Report Number
    3006630150-2025-00609
    Event Type
    Injury
    Date Received
    February 10, 2025
    Date of Event
    July 7, 2023
    Report Date
    February 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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: 5152132 / 5152133.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SPASM AND HOT BURNING PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE AND HAD DIFFICULTY CHARGING THE IPG. IT WAS ALSO NOTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF DUE TO HIGH IMPEDANCES ON SPINAL CORD STIMULATOR (SCS) LEADS. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND SCS LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684453 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 356363 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention