BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 24477783 · Received March 2, 2026

    Report

    Report Number
    3006630150-2026-01178
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    July 15, 2025
    Report Date
    April 22, 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
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE (IPG AND LEADS) WERE NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. IT WAS CONFIRMED THESE DEVICES MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    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: 5031269. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 21562676. UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. BATCH: 21738704. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES AND LEAD MIGRATION CONFIRMED THROUGH X RAY IMAGING. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM REPLACEMENT PROCEDURE, DURING WHICH A PADDLE LEAD WAS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND ALL EXPLANTED DEVICES WERE NOT RETURNED DUE TO FACILITY POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES AND LEAD MIGRATION CONFIRMED THROUGH X RAY IMAGING. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM REPLACEMENT PROCEDURE, DURING WHICH A PADDLE LEAD WAS IMPLANTED. 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
    171436 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 333405 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention