BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 23069760 · Received September 16, 2025

    Report

    Report Number
    3006630150-2025-07679
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    July 30, 2025
    Report Date
    October 27, 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
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 5143515, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 5154304, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IT WAS NOTED THAT PATIENTS SPINAL CORD STIMULATOR LEAD HAD MIGRATED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM REPLACEMENT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IT WAS NOTED THAT PATIENTS SPINAL CORD STIMULATOR LEAD HAD MIGRATED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM REPLACEMENT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POST OPERATIVELY AND THE EXPLANTED DEVICE WILL NOT BE RETURN DUE FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2640336 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 357568 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention