BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME

    MDR report key: 20684247 · Received November 14, 2024

    Report

    Report Number
    3006630150-2024-07812
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    June 12, 2024
    Report Date
    November 14, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED 3 MONTHS AGO FROM DATE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN:M365SC2218700. MODEL:SC-2218-70. SERIAL: (B)(6). BATCH:7091134/7091354/7091567/7091506. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN:M365SC43160. MODEL:SC-4316. BATCH:29238950.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT. IT WAS NOTED THAT THE PATIENT PULLED OUT THE SPINAL CORD STIMULATION (SCS) LEAD FROM THE CERVICAL REGION AND THEY HAVE BEEN HALFWAY OUT OF THE PATIENTS BODY. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224427 WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1432 214736 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention