BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 19247450 · Received May 6, 2024

    Report

    Report Number
    3006630150-2024-02887
    Event Type
    Injury
    Date Received
    May 6, 2024
    Date of Event
    April 12, 2024
    Report Date
    June 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: SC-2218-50. MODEL: M365SC2218500. SERIAL: (B)(6). BATCH: 7110491/7110577.

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT DUE TO AN UNKNOWN REASON. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR THE REPLACEMENT WAS DUE TO THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF. THE LEADS WERE ALSO REPLACED DURING THE PROCEDURE AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE KEPT THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT DUE TO AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767848 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 545370 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention