BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9118605 · Received September 25, 2019

    Report

    Report Number
    3006630150-2019-05302
    Event Type
    Injury
    Date Received
    September 25, 2019
    Date of Event
    September 5, 2019
    Report Date
    September 25, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8216-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7051957, MODEL/CATALOG DESCRIPTION: ARTISAN LEAD 70 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD INFECTION. SYMPTOM OF RASH WAS NOTED ON THE INCISION SITES. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PHYSICIAN CONFIRMED THAT THE INFECTION WAS NOT DEVICE NOR PROCEDURE RELATED. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913659 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 357298 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention