BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 24126603 · Received January 20, 2026

    Report

    Report Number
    3006630150-2026-00429
    Event Type
    Injury
    Date Received
    January 20, 2026
    Date of Event
    August 26, 2025
    Report Date
    April 1, 2026
    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: 7070785. UDI:(B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500 . MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 7070820. UDI:(B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS THE IMPLANTABLE PULSE GENERATOR (IPG) AND SPINAL CORD STIMULATOR (SCS) LEADS WERE NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. LABELING REVIEW REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. INVESTIGATION CONCLUSION BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS EXPERIENCING DISCOMFORT WITH THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS NOTED THAT THE PATIENT WAS NO LONGER GETTING ADEQUATE PAIN RELIEF AND WAS ALSO EXPERIENCING SHOCKING SENSATION. DURING A PROGRAM OPTIMIZATION SESSION, IT WAS DISCOVERED THAT THE LEFT SPINAL CORD STIMULATOR (SCS) LEAD HAD HIGH IMPEDANCES. 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 DUE TO FACILITY POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS EXPERIENCING DISCOMFORT WITH THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS NOTED THAT THE PATIENT WAS NO LONGER GETTING ADEQUATE PAIN RELIEF AND WAS ALSO EXPERIENCING SHOCKING SENSATION. DURING A PROGRAM OPTIMIZATION SESSION, IT WAS DISCOVERED THAT THE LEFT SPINAL CORD STIMULATOR (SCS) LEAD HAD HIGH IMPEDANCES. 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 DUE TO FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174510 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 364044 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention