BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 20035908 · Received August 22, 2024

    Report

    Report Number
    3006630150-2024-05490
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    August 1, 2023
    Report Date
    August 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-6, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 5141410. BRAND NAME: LINEAR 3-6, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 5151687. BRAND NAME: LINEAR 3-6, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 5128964. BRAND NAME: LINEAR 3-6, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 5137319.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM. IT WAS NOTED THAT THE PATIENT HAD A RECENT COMPUTERIZED TOMOGRAPHY SCAN (CT SCAN) WHICH SHOWED INCREASED DEGENERATION OF THE PATIENTS' SPINE, WHICH THE PHYSICIAN CONCLUDED COULD BE THE CAUSE OF THE INCREASED PAIN. MULTIPLE REPROGRAMMING SESSIONS WERE DONE, HOWEVER, WAS ATTEMPTED BUT DID NOT RESOLVE THE ISSUE, THE PATIENT DECLINED ADDITIONAL REPROGRAMMING AND REQUESTED THAT THE SYSTEM BE EXPLANTED. THE PATIENT IS DOING WELL POST OPERATIVE, AND THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218268 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 357113 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention