BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 24069336 · Received January 14, 2026

    Report

    Report Number
    3006630150-2026-00329
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    December 16, 2025
    Report Date
    April 14, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES SC-1216 SERIAL NUMBER 803169 AND THE SC-2218-50 SERIAL NUMBER 7171068 AND 7163596 WERE NOT RETURNED FOR ANALYSIS. HOWEVER, 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. THE DEVICE WAS NOT RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS AND THE COMPLAINT AS REPORTED WAS NOT ABLE TO BE CONFIRMED. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF: CAUSE NOT ESTABLISHED. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7171068, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7163596, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6) BATCH: 7171068 UDI: (B)(4) PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7163596. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICES WERE REVISED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICES WERE REVISED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465991 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 803169 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention