BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 19047707 · Received April 4, 2024

    Report

    Report Number
    3006630150-2024-02080
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    March 15, 2024
    Report Date
    April 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7130938/7131278.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS POCKET INCISION HAS COMPLETELY GASHED OPEN DUE TO A NON-DEVICE RELATED FALL. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED AS THEY WERE NOT RELEASED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58219 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 574320 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention