BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 23973803 · Received January 6, 2026

    Report

    Report Number
    3006630150-2026-00099
    Event Type
    Injury
    Date Received
    January 6, 2026
    Date of Event
    December 10, 2025
    Report Date
    March 19, 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
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7171012/7170005. UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. BATCH: 37398190. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS, MEDIA REVIEW, DEVICE ANALYSIS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. 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. 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: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. SYMPTOMS OF REDNESS AND PUS WERE NOTED AND THE IPG WAS EXPOSED. DISCOLORED DISCHARGE FROM SURGICAL SITE WAS NOTED. THE PHYSICIAN DOES NOT BELIEVE IT WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. SYMPTOMS OF REDNESS AND PUS WERE NOTED AND THE IPG WAS EXPOSED. DISCOLORED DISCHARGE FROM SURGICAL SITE WAS NOTED. THE PHYSICIAN DOES NOT BELIEVE IT WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38562 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 804313 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention