BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 25084763 · Received May 5, 2026

    Report

    Report Number
    3006630150-2026-02905
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 5, 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
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: MODEL NUMBER/CATALOG NUMBER: SC-9208-55. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7070742. MODEL/CATALOG DESCRIPTION: PRECISION S8 ADAPTER, 55CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-9208-55. BATCH/LOT NUMBER: 7070715. SERIAL NUMBER: (B)(6). MODEL/CATALOG DESCRIPTION: PRECISION S8 ADAPTER, 55CM. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE BATTERY INCISION LEFT FLANK. SYMPTOMS OF CHILLS, PAIN, WARM TO TOUCH 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
    97454 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 815373 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1