BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME

    MDR report key: 23534368 · Received November 12, 2025

    Report

    Report Number
    3006630150-2025-10310
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    October 10, 2025
    Report Date
    December 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8336500 MODEL: SC-8336-50 SERIAL: (B)(6). BATCH: 7092527 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) INCISION SITE IS NOT HEALING. PATIENT HAD HIS STAPLES REMOVED AND STERI-STRIPS APPLIED. THERE ARE NO SIGNS OR SYMPTOMS OF INFECTION, BUT HE HAS BEEN PLACED ON AN ORAL ANTIBIOTIC. BLOOD CULTURES WERE NEGATIVE FOR INFECTION. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) REMOVAL PROCEDURE. PATIENT IS DOING WELL POSTOPERATIVELY. NOTHING WILL BE RETURNED. THE HOSPITAL DISPOSED OF THE EXPLANATION DEVICE. NO DEVICE MALFUNCTION IS SUSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) INCISION SITE IS NOT HEALING. PATIENT HAD HIS STAPLES REMOVED AND STERI-STRIPS APPLIED. THERE ARE NO SIGNS OR SYMPTOMS OF INFECTION, BUT HE HAS BEEN PLACED ON AN ORAL ANTIBIOTIC. BLOOD CULTURES WERE NEGATIVE FOR INFECTION. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) REMOVAL PROCEDURE. PATIENT IS DOING WELL POSTOPERATIVELY. NOTHING WILL BE RETURNED. THE HOSPITAL DISPOSED OF THE EXPLANATION DEVICE. NO DEVICE MALFUNCTION IS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2592861 WAVEWRITER ALPHA? PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1432 239929 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention