BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 20807190 · Received November 28, 2024

    Report

    Report Number
    3006630150-2024-08239
    Event Type
    Injury
    Date Received
    November 28, 2024
    Date of Event
    August 4, 2024
    Report Date
    November 28, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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-PADDLE LEADS, UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL#: (B)(6), BATCH: 7083159.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE. IT WAS ALSO NOTED, THAT THE PATIENT HAD UNDESIRED SENSATION EVEN WHEN STIMULATION WAS OFF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2614479 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 578793 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention