BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 18927644 · Received March 19, 2024

    Report

    Report Number
    3006630150-2024-01575
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    February 28, 2020
    Report Date
    March 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED THE DAY THE DEVICE WAS IMPLANTED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(6), BATCH: 7051243.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE EXPLANTED DEVICES WILL NOT BE RETURNED PER HOSPITAL POLICY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2277066 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 365146 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention