BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 23431098 · Received October 30, 2025

    Report

    Report Number
    3006630150-2025-09823
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    October 9, 2025
    Report Date
    March 3, 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
    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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6) BATCH: 5148289 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6) BATCH: 5151817 UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43180 MODEL: SC-4318 BATCH: 23928479 UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULT: THE DEVICE WAS NOT RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS AND THE COMPLAINT AS REPORTED WAS NOT ABLE TO BE CONFIRMED. DEVICE HISTORY RECORD: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET SPECIFICATION PRIOR TO SHIPPING. NO MANUFACTURING DEVIATIONS WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE EVENT REPORTED. INVESTIGATION CONCLUSION: 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 UNABLE TO EXCLUDE DEVICE PROBLEM WILL BE USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED AND NOT RETURNED. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED AND NOT RETURNED. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369207 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 353779 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention