BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 20292502 · Received September 24, 2024

    Report

    Report Number
    3006630150-2024-06390
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    January 26, 2024
    Report Date
    March 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7103475/7103394.

    Additional Manufacturer Narrative · 0

    THE RETURNED IMPLANTABLE PULSE GENERATOR (IPG) WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE REPORTED EVENT WAS NOT CONFIRMED. THE IPG DISPLAYED TYPICAL CHARACTERISTICS THROUGHOUT BOTH VISUAL AND FUNCTIONAL ASSESSMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR BATTERY AND LEAD REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POST OPERATIVELY AND THE EXPLANTED LEAD WILL NOT BE RETURN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR BATTERY AND LEAD REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POST OPERATIVELY AND THE EXPLANTED LEAD WILL NOT BE RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105146 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 532940 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention