BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 18372545 · Received December 21, 2023

    Report

    Report Number
    3006630150-2023-08024
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    September 27, 2023
    Report Date
    December 21, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7082007/7082284.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED INFECTION DUE TO BATTERY SITE INCISION WOULD NOT CLOSE. THE PHYSICIAN BELIEVED THE INFECTION WAS NO DEVICE RELATED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURN AS IT WAS DISPOSED PER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050912 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 567651 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention