BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 24897258 · Received April 16, 2026

    Report

    Report Number
    3006630150-2026-02388
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    October 1, 2025
    Report Date
    April 16, 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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED ABOUT A MONTH AGO PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2318-70. SERIAL NUMBER:(B)(6). BATCH/LOT NUMBER: 5002178. MODEL/CATALOG DESCRIPTION: INFINION PRO LEAD KIT, 16 CONTACT, 70CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2318-70. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5002307. MODEL/CATALOG DESCRIPTION: INFINION PRO LEAD KIT, 16 CONTACT, 70CM 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 STATUS WAS GOOD POSTOPERATIVELY. PRODUCT WAS RETAINED BY FACILITY AND WILL NOT BE RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553107 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 765634 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1