BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10762933 · Received October 30, 2020

    Report

    Report Number
    3006630150-2020-05261
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    October 12, 2020
    Report Date
    October 30, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 7071859 / 7071956.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG SITE. IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING FEVER, REDNESS AT THE POCKET SITE, VOMITING, PAIN AND DIARRHEA. IT WAS UNKNOWN IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED AND THE CAUSE WAS ALSO UNKNOWN. IT WAS NOTED THAT THE PATIENT WAS PRONE TO SEPSIS AFTER MOST OF THE PREVIOUS SURGERIES. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227148 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 368839 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention