BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 21207936 · Received January 22, 2025

    Report

    Report Number
    3006630150-2025-00124
    Event Type
    Injury
    Date Received
    January 22, 2025
    Date of Event
    September 12, 2023
    Report Date
    January 22, 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
    MI, 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: M365SC2316500. MODEL: SC-2316-50. SERIAL: (B)(6). BATCH: 20285492. PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138550. MODEL: SC-3138-55. SERIAL: (B)(6). BATCH: 7003304/7012420/7012673/7012581. PRODUCT FAMILY: SCS-SPLITTERS. UPN: M365SC3400300. MODEL: SC-3400-30. SERIAL: (B)(6). BATCH: 19873343.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND ALL EXPLANTED DEVICES WERE NOT RETURNED DUE TO FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621877 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 337573 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention