BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 24864059 · Received April 13, 2026

    Report

    Report Number
    3006630150-2026-02304
    Event Type
    Injury
    Date Received
    April 13, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 13, 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
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-70 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7091794 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2218-70 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7081432 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2218-70 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7089712 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2218-70 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7090374 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4318 BATCH/LOT NUMBER: 27975156 MODEL/CATALOG DESCRIPTION: CLIK X ANCHOR STERILE KIT UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE BATTERY SITE WITH SYMPTOMS OF INCREASING PAIN, HEADACHE, SWELLING AND A PINK RASH. THE PHYSICIAN TRIED TO ASPIRATE, FIRST 3 NEEDLE POKES HE GOT NOTHING OUT AND SWITCHED TO A BIGGER NEEDLE AND WAS ABLE TO PULL OUT ONLY 1CC OF BLOODY STUFF. THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) AND BLOOD WORK. COMPUTED TOMOGRAPHY (CT) CONFIRMED AN ABSCESS. THE THORACIC LEADS AND BATTERY SITE HAD FLUIDS. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. CULTURES CAME BACK POSITIVE FOR STAPHYLOCOCCUS 4+. PATIENT WAS GIVEN ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518509 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 766705 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention