BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 19360630 · Received May 21, 2024

    Report

    Report Number
    3006630150-2024-03274
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    May 2, 2024
    Report Date
    May 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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-MRI. UPN: M365SC8416700. MODEL: SC-8416-70. SERIAL: (B)(6). BATCH: 7070619.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN. MAGNETIC RESONANCE IMAGING (MRI) REVEALED THAT THE CERVICAL SPINAL CORD STIMULATOR WAS BEING COMPRESSED BY THE PADDLE. THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE. THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220406 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 594904 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention