BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME

    MDR report key: 19388175 · Received May 23, 2024

    Report

    Report Number
    3006630150-2024-03347
    Event Type
    Injury
    Date Received
    May 23, 2024
    Date of Event
    May 1, 2024
    Report Date
    May 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7093550/7084871.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS IPG REACHED END OF LIFE. IT WAS ALSO NOTED THAT THE PATIENT WAS NOT GETTING ADEQUATE COVERAGE DUE TO HIGH IMPEDANCES ON THE LEAD. THE PATIENT UNDERWENT IPG AND LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055903 WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1432 212255 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention