BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 24769510 · Received April 2, 2026

    Report

    Report Number
    3006630150-2026-02018
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    March 7, 2026
    Report Date
    April 2, 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
    FL, 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-2218-50 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7164465 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2218-50 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7173365 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING ITCHING, BURNING AND REDNESS TO INCISION SITE. THE PATIENT WENT TO EMERGENCY ROOM (ER) AND THEY DIAGNOSED HIM WITH CONTACT DERMATITIS AND THEN CELLULITIS. THE PHYSICIAN THOUGHT THIS WAS A RESPONSE TO LOCALIZED ANTIBIOTICS. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. THE PATIENT WAS CURRENTLY MANAGED BY INFECTIOUS DISEASE WITH INTRAVENOUS (IV) ANTIBIOTICS FOR METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832187 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 803962 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention