BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16048569 · Received December 26, 2022

    Report

    Report Number
    3006630150-2022-07291
    Event Type
    Injury
    Date Received
    December 26, 2022
    Date of Event
    December 24, 2021
    Report Date
    December 26, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7082235/7082283. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, , MODEL: SC-2352-70, SERIAL: (B)(4), BATCH: 7073383. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 7072590. PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138250, MODEL: SC-3138-25, SERIAL: (B)(4), BATCH: 7071191/7071215/7070866/7071185.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DESPITE REPROGRAMMING ATTEMPTS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. NO DEVICE MALFUNCTION WAS SUSPECTED. ALL EXPLANTED DEVICE COMPONENTS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2785899 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 529140 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention