BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 24539105 · Received March 6, 2026

    Report

    Report Number
    3006630150-2026-01346
    Event Type
    Injury
    Date Received
    March 6, 2026
    Date of Event
    July 20, 2023
    Report Date
    March 6, 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
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED SINCE IMPLANT PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7128735, 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: 7130444, 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. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. PATIENT RECOVERED POSTOPERATIVELY. THE EXPLANTED DEVICES WERE UNABLE TO RETURN PER SURGERY CENTER POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599197 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 561227 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention