BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11802297 · Received May 10, 2021

    Report

    Report Number
    3006630150-2021-02010
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    April 19, 2021
    Report Date
    May 10, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7072988.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE BATTERY SITE. SYMPTOMS OF DRAINAGE AND INCISION OPENING WERE NOTED. THE PHYSICIAN DID NOT BELIEVE THAT THE INFECTION WAS PROCEDURE RELATED BUT IT WAS UNKNOWN IF DEVICE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS PLACED ON ANTIBIOTICS. THE EXPLANTED DEVICES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698182 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 375802 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention