BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 20468092 · Received October 16, 2024

    Report

    Report Number
    3006630150-2024-07034
    Event Type
    Injury
    Date Received
    October 16, 2024
    Date of Event
    September 26, 2021
    Report Date
    October 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED THREE YEARS AGO FROM THE DATE THE MANUFACTURER WAS MADE AWARE. D6B: EXPLANT DATE: THREE YEARS AGO FROM THE AWARE DATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS: UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(6), BATCH: 7071317.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION. NO DEVICE MALFUNCTION WAS SUSPECTED. ALL COMPONENTS WERE EXPLANTED AND DISCARDED PER HOSPITAL POLICY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202321 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 366381 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention