BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 23895370 · Received December 26, 2025

    Report

    Report Number
    3006630150-2025-11671
    Event Type
    Injury
    Date Received
    December 26, 2025
    Date of Event
    March 11, 2025
    Report Date
    March 17, 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

    INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE; HOWEVER, RESPONSE WAS NOT RECEIVED. DEVICE HISTORY RECORD: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF UNABLE TO EXCLUDE DEVICE PROBLEM.

    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: 7070176/7056502. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING FREQUENT IMPLANTABLE PULSE GENERATOR (IPG) CHARGING AND THE LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD AND IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING FREQUENT IMPLANTABLE PULSE GENERATOR (IPG) CHARGING AND THE LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD AND IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716909 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 363851 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention