BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 24054588 · Received January 13, 2026

    Report

    Report Number
    3006630150-2026-00304
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    December 24, 2025
    Report Date
    March 24, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SC-2218-70. (B)(6) -TW# (B)(4). SC-2218-70. (B)(6) -TW# (B)(4). SC-3138-25. (B)(6) -TW# (B)(4). SC-3138-25. (B)(6) -TW# (B)(4). THE LEADS AND EXTENSIONS WERE NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. IT WAS CONFIRMED THESE DEVICES MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED.

    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: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7072051/7072104, UDI: (B)(4). PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138250, MODEL: SC-3138-25, SERIAL: (B)(6), BATCH: 5085079/7055320, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT AROUND THE POCKET FOR THE BATTERY. SYMPTOMS OF WARMTH, REDNESS, SOME DRAINAGE WERE NOTED. THE PHYSICIAN CONFIRMED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT WAS ADMINISTERED WITH ANTIBIOTICS AND UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURNED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS ADMITTED AT THE HOSPITAL UNTIL READY FOR DISCHARGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT AROUND THE POCKET FOR THE BATTERY. SYMPTOMS OF WARMTH, REDNESS, SOME DRAINAGE WERE NOTED. THE PHYSICIAN CONFIRMED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT WAS ADMINISTERED WITH ANTIBIOTICS AND UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURNED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS ADMITTED AT THE HOSPITAL UNTIL READY FOR DISCHARGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT AROUND THE POCKET FOR THE BATTERY. SYMPTOMS OF WARMTH, REDNESS, SOME DRAINAGES WERE NOTED. THE PHYSICIAN CONFIRMED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT WAS ADMINISTERED WITH ANTIBIOTICS AND UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55969 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 802607 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention