BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 24731676 · Received March 30, 2026

    Report

    Report Number
    3006630150-2026-01923
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 6, 2026
    Report Date
    May 20, 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
    UT, 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: 7111407 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: 7111719 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2158-70 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 5005030 MODEL/CATALOG DESCRIPTION: LINEAR LEAD KIT 70 CM UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2158-70 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 5005040 MODEL/CATALOG DESCRIPTION: LINEAR LEAD KIT 70 CM UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SHOCKING SENSATIONS IN HER RIBS AND CHEST. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. THE PATIENT WAS STABLE POSTOPERATIVELY. THE FACILITY DISPOSED OF THE STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264934 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 513849 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1