BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 24539539 · Received March 6, 2026

    Report

    Report Number
    3006630150-2026-01356
    Event Type
    Injury
    Date Received
    March 6, 2026
    Date of Event
    February 17, 2026
    Report Date
    May 11, 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
    IL, 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: 7131689, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4) MODEL NUMBER/CATALOG NUMBER: SC-2218-50 SERIAL NUMBER: 7132512 BATCH/LOT NUMBER: 7132512, 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 INADEQUATE PAIN RELIEF. PROGRAM OPTIMIZATION WAS ATTEMPTED AND WAS NOT SUCCESSFUL. THE PATIENT UNDERWENT IMPLANTABLE PULSE GENERATOR (IPG) EXPLANT PROCEDURE. PATIENT IS DOING FINE POSTOPERATIVELY. FACILITY DOES NOT ALLOW RETURN OF IMPLANTED DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153358 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 577521 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention