BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9638557 · Received January 28, 2020

    Report

    Report Number
    3006630150-2020-00228
    Event Type
    Injury
    Date Received
    January 28, 2020
    Date of Event
    January 8, 2020
    Report Date
    February 13, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INFECTION AND WAS DOING WELL POSTOPERATIVELY. IT WAS ALSO REPORTED THAT THE INFECTION WAS NOT DEVICE RELATED. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENTS IPG AND LEAD INCISION SITE WERE SWELLING. IT WAS BELIEVED THAT THE PATIENT HAD A SUSPECTED INFECTION AND IT WAS UNKNOWN WHAT CAUSED IT. THE PATIENT WILL UNDERGO EITHER A CLEAN OUT OR EXPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8216-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7012060, MODEL/CATALOG DESCRIPTION: ARTISAN LEAD 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS IPG AND LEAD INCISION SITE WERE SWELLING. IT WAS BELIEVED THAT THE PATIENT HAD A SUSPECTED INFECTION AND IT WAS UNKNOWN WHAT CAUSED IT. THE PATIENT WILL UNDERGO EITHER A CLEAN OUT OR EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102645 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 356143 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention