BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 18805696 · Received February 29, 2024

    Report

    Report Number
    3006630150-2024-01071
    Event Type
    Injury
    Date Received
    February 29, 2024
    Date of Event
    November 6, 2023
    Report Date
    April 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED IMPLANTABLE PULSE GENERATOR (IPG) WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED A FEW MONTHS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8336700. MODEL: SC-8336-70. SERIAL: (B)(6). BATCH: 7071474.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF DESPITE REPROGRAMMING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. THE EXPLANTED LEAD WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF DESPITE REPROGRAMMING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. THE EXPLANTED LEAD WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444612 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 520730 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention