BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME

    MDR report key: 17323774 · Received July 14, 2023

    Report

    Report Number
    3006630150-2023-04115
    Event Type
    Injury
    Date Received
    July 14, 2023
    Date of Event
    June 19, 2023
    Report Date
    July 14, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: 7090773 / 7095447.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS INCISION AT THE IPG SITE HAD OPENED DUE TO A NON-DEVICE RELATED ACCIDENT. THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) AND UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806100 WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1432 208294 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention