BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 25308380 · Received May 27, 2026

    Report

    Report Number
    3006630150-2026-03544
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    March 5, 2026
    Report Date
    May 27, 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
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2352-70. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7072243. MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 70 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2352-70. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7072437. MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 70 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4318. SERIAL NUMBER: NA. BATCH/LOT NUMBER: 28865921. 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 WORSENING AND DEBILITATING NECK PAIN WHICH WAS THE PAIN AREA TREATED WITH A CERVICAL SPINAL CORD STIMULATOR (SCS). A NEW IMAGING WAS PERFORMED, AND THE PHYSICIAN RECOMMENDED A POSTERIOR CERVICAL FUSION. IN PREPARATION FOR THE SAID PROCEDURE, THE PATIENT SUBSEQUENTLY UNDERWENT AN SCS SYSTEM EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522599 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 368800 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1