BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 19586166 · Received June 21, 2024

    Report

    Report Number
    3006630150-2024-03994
    Event Type
    Injury
    Date Received
    June 21, 2024
    Date of Event
    May 29, 2024
    Report Date
    June 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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: M365SC2218500. MODEL: SC-2218-50. SERIAL: 7133308/7133299. BATCH: 7133308/7133299.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A FLUID BUILDUP AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE AND HAD TO BE DRAINED EVERY COUPLE OF WEEKS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163431 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 586448 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention