BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME

    MDR report key: 19493807 · Received June 8, 2024

    Report

    Report Number
    3006630150-2024-03696
    Event Type
    Injury
    Date Received
    June 8, 2024
    Date of Event
    May 16, 2024
    Report Date
    June 8, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 7079313/7080828.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS WERE EXPOSED AT THE IPG POCKET SITE. THE PHYSICIAN BELIEVED THAT PATIENT TAKING BLOOD THINNERS QUICKLY AFTER IMPLANT COULD HAVE CONTRIBUTED TO THE LEAD EXPOSURE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2326876 WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1432 216494 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention