BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 25273356 · Received May 25, 2026

    Report

    Report Number
    3006630150-2026-03478
    Event Type
    Injury
    Date Received
    May 25, 2026
    Date of Event
    December 1, 2024
    Report Date
    May 25, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED DECEMBER 2024. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2317-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 5169920, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2317-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 5171775, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4316, BATCH/LOT NUMBER: 22890120, MODEL/CATALOG DESCRIPTION: CLIK ANCHOR, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT COULD NO LONGER FEEL THE THERAPY AND WAS EXPERIENCING COMMUNICATION ISSUES BETWEEN THE REMOTE CONTROL AND THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332821 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 367882 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1