BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME

    MDR report key: 24439439 · Received February 25, 2026

    Report

    Report Number
    3006630150-2026-01085
    Event Type
    Injury
    Date Received
    February 25, 2026
    Date of Event
    December 1, 2025
    Report Date
    May 9, 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
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED DECEMBER 2025. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8336500 MODEL: SC-8336-50 SERIAL: (B)(6). BATCH: 7093169 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION ON THE LEFT FLANK OVER THE TOP OF THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. IT WAS NOTED THAT THE WOUND SITE WAS DRAINING AND THE PHYSICIAN CONFIRMED THAT INFECTION WAS DEVICE RELATED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AND THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY. A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS PLACED FOLLOWING THE PROCEDURE AND PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PATIENT WAS DOING WELL UPON FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341354 WAVEWRITER ALPHA? PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1432 242525 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention