BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10169484 · Received June 18, 2020

    Report

    Report Number
    3006630150-2020-02523
    Event Type
    Injury
    Date Received
    June 18, 2020
    Date of Event
    February 17, 2020
    Report Date
    June 18, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: (B)(4), MODEL: SC-4316, BATCH: 24001100. PRODUCT FAMILY: SCS-PADDLE LEADS UPN: (B)(4), MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7051406.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD AN INFECTION AT THE IPG INCISION SITE WHEREIN FLUID DRAINAGE WAS NOTED. THE CAUSE OF INFECTION WAS UNKNOWN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL COMPONENTS WERE REMOVE AND WILL NOT BE RETURNED. UPON RECENT CONSULTATION WITH THE PHYSICIAN, THE PATIENT WAS REPORTED TO BE CLEARED OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631370 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 363667 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention