BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16728804 · Received April 12, 2023

    Report

    Report Number
    3006630150-2023-01972
    Event Type
    Injury
    Date Received
    April 12, 2023
    Date of Event
    March 23, 2023
    Report Date
    April 12, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT : 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: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7120134. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 5019797/5030880. PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43160, MODEL: SC-4316, BATCH: 21964602/28303967.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IPG WAS EXPOSED AT THE INCISION SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL DEVICE COMPONENTS WERE REMOVED AND WERE KEPT BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455603 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 554567 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention