BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16097281 · Received January 4, 2023

    Report

    Report Number
    3006630150-2022-07495
    Event Type
    Injury
    Date Received
    January 4, 2023
    Date of Event
    December 7, 2022
    Report Date
    September 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    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: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC236650E0, MODEL: SC-2366-50E, SERIAL: (B)(4), BATCH: 7072365; PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 7072377.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-6; UPN: M365SC2366700; MODEL: SC-2366-70; SERIAL: (B)(6). BRAND NAME: LINEAR 3-6; UPN: M365SC2366700; MODEL: SC-2366-70; SERIAL: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EXASPERATION OF THEIR PRE-EXISTING NECK PAIN DUE TO CERVICAL STENOSIS ISSUES. REPROGRAMMING WAS ATTEMPTED BUT DID NOT RESOLVE THE PATIENT'S PAIN. THEREFORE, THE PATIENT HAD TO TURN OFF THEIR SPINAL CORD STIMULATOR (SCS) STIMULATION THERAPY AND UNDERWENT A NERVE BLOCK PROCEDURE IN AN ATTEMPT TO ALLEVIATE THE PAIN. THE PATIENT IS DOING WELL AND THE SCS STIMULATION THERAPY REMAINS OFF. A COMPUTERIZED TOMOGRAPHY SCAN (CT SCAN) WAS PERFORMED BUT THE RESULTS ARE UNKNOWN. THE DEVICES REMAIN IMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EXASPERATION OF THEIR PREEXISTING NECK PAIN DUE TO CERVICAL STENOSIS ISSUES. REPROGRAMMING WAS ATTEMPTED BUT DID NOT RESOLVE THE PATIENTS' PAIN. THEREFORE, THE PATIENT HAD TO TURN OFF THEIR SPINAL CORD STIMULATOR (SCS) STIMULATION THERAPY AND UNDERWENT A NERVE BLOCK PROCEDURE IN AN ATTEMPT TO ALLEVIATE THE PAIN. THE PATIENT IS DOING WELL AND THE SCS STIMULATION THERAPY REMAINS OFF. A COMPUTERIZED TOMOGRAPHY SCAN (CT SCAN) WAS PERFORMED BUT THE RESULTS ARE UNKNOWN. THE DEVICES REMAIN IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED WITH THE CORRECT MODEL AND SERIAL NUMBERS FOR THE TWO RELATED LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471176 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 532562 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other