BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 15859477 · Received November 23, 2022

    Report

    Report Number
    3006630150-2022-06511
    Event Type
    Injury
    Date Received
    November 23, 2022
    Date of Event
    November 10, 2022
    Report Date
    November 23, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2352700; MODEL: SC-2352-70; SERIAL: (B)(4); BATCH: 7072713. PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2366700; MODEL: SC-2366-70; SERIAL: (B)(4); BATCH: 7072092. PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2366700; MODEL: SC-2366-70; SERIAL: (B)(4); BATCH: 7072171.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION AND UNDERWENT AN EXPLANT PROCEDURE OF THEIR SPINAL CORD STIMULATION (SCS) SYSTEM. THE DEVICES WERE NOT RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758165 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 520776 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention