BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 18414159 · Received December 28, 2023

    Report

    Report Number
    3006630150-2023-08214
    Event Type
    Injury
    Date Received
    December 28, 2023
    Date of Event
    July 26, 2021
    Report Date
    January 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    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 OVER 2 YEARS AGO FROM THE DATE THE MANUFACTURER WAS MADE AWARE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 7071957/7072057.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND PAIN AT THE IPG SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND PAIN AT THE IPG SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEADS WERE ALSO EXPLANTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360830 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 366852 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention