BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 17917157 · Received October 11, 2023

    Report

    Report Number
    3006630150-2023-06178
    Event Type
    Injury
    Date Received
    October 11, 2023
    Date of Event
    September 19, 2023
    Report Date
    October 11, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7077613/5150631.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE POCKET SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WERE ALL DEVICE EXPLANTED. THE EXPLANTED DEVICE WILL NOT BE RETURN. THE PATIENT WAS PLACED UNDER ANTIBIOTICS. THE EXPLANTED DEVICE WAS NOT RELEASED BY THE FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2115055 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 559500 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention