BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME

    MDR report key: 24108032 · Received January 19, 2026

    Report

    Report Number
    3006630150-2026-00398
    Event Type
    Injury
    Date Received
    January 19, 2026
    Date of Event
    September 29, 2025
    Report Date
    March 27, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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: 7130645, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7129292, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    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 KNOWN INHERENT RISK OF DEVICE WILL BE USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S WAS IMPLANTABLE PULSE GENERATOR (IPG) WAS CAUSING PAIN AND DISCOMFORT. IT WAS ALSO STATED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND THE SPINAL CORD STIMULATOR (SCS) LEADS HAD MIGRATED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG WAS EXPLANTED AND THE LEADS WERE REPOSITIONED. THE EXPLANTED IPG WAS RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S WAS IMPLANTABLE PULSE GENERATOR (IPG) WAS CAUSING PAIN AND DISCOMFORT. IT WAS ALSO STATED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND THE SPINAL CORD STIMULATOR (SCS) LEADS HAD MIGRATED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG WAS EXPLANTED AND THE LEADS WERE REPOSITIONED. THE EXPLANTED IPG WAS RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168417 WAVEWRITER ALPHA? PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1432 210578 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention