BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 24505892 · Received March 4, 2026

    Report

    Report Number
    3006630150-2026-01242
    Event Type
    Injury
    Date Received
    March 4, 2026
    Date of Event
    January 1, 2025
    Report Date
    May 9, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE APPROXIMATED, EVENT OCCURRED IN (B)(6) 2025. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). INVESTIGATION RESULTS: ALL EXPLANTED DEVICES WERE NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD: IT WAS CONFIRMED THAT ALL DEVICES MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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: ALL EXPLANTED DEVICES WERE NOT RETURNED FOR ANALYSIS AND THE COMPLAINT AS REPORTED COULD NOT BE CONFIRMED. RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THEREFORE, THIS INVESTIGATION IS UNABLE TO DETERMINE A PROBABLE CAUSE FOR THE COMPLAINT AND THE CONCLUSION CODE CAUSE NOT ESTABLISHED WILL BE USED.

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE APPROXIMATED, EVENT OCCURRED IN JANUARY 2025. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 5091214 / 7071926. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6) BATCH: 7071926 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) WAS CAUSING PAIN. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND LEADS WERE EXPLANTED AND THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) WAS CAUSING PAIN. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND LEADS WERE EXPLANTED AND THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449926 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 359719 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1