BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 25176414 · Received May 14, 2026

    Report

    Report Number
    3006630150-2026-03147
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    April 22, 2023
    Report Date
    May 14, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED THREE YEARS 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: 5117157, 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: 5125040, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM, UNIQUE IDENTIFIER (UDI)#: (B)(4), MODEL NUMBER/CATALOG NUMBER: SC-3138-25, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 2000022159, MODEL/CATALOG DESCRIPTION: LEAD EXTENSION KIT 25CM, UNIQUE IDENTIFIER (UDI)#: (B)(4), MODEL NUMBER/CATALOG NUMBER: SC-3138-25, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7042729, MODEL/CATALOG DESCRIPTION: LEAD EXTENSION KIT 25CM, UNIQUE IDENTIFIER (UDI)#: (B)(4), MODEL NUMBER/CATALOG NUMBER: SC-8352-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 18338876, MODEL/CATALOG DESCRIPTION: COVEREDGE X 32 SURGICAL LEAD KIT 50 CM, UNIQUE IDENTIFIER (UDI)#: (B)(4), MODEL NUMBER/CATALOG NUMBER: SC-4318, BATCH/LOT NUMBER: 23254101, MODEL/CATALOG DESCRIPTION: CLIK X ANCHOR STERILE KIT, UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435611 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 347845 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1