BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 19544126 · Received June 15, 2024

    Report

    Report Number
    3006630150-2024-03869
    Event Type
    Injury
    Date Received
    June 15, 2024
    Date of Event
    May 7, 2024
    Report Date
    June 14, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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: 7141909/7141971.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD INFECTION AT THE AT THE IPG AND LEAD SITES. IT WAS NOTED THAT THE PATIENT HAD PAIN AND DRAINAGE AT THE IPG SITE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE NOR PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE DISPOSED BY THE MEDICAL FACILITY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783747 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 750026 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Unknown Required Intervention