BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11377690 · Received February 25, 2021

    Report

    Report Number
    3006630150-2021-00628
    Event Type
    Injury
    Date Received
    February 25, 2021
    Date of Event
    February 3, 2021
    Report Date
    March 22, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. ALL DEVICE COMPONENTS WERE EXPLANTED. THE EXPLANTED IPG AND LEADS WILL NOT BE RETURNED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT NO LONGER NEEDED DEVICE DUE TO SCHEDULED BACK SURGERY.

    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-2218-50, SERIAL: (B)(4), BATCH: 5153101/7072738.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. ALL DEVICE COMPONENTS WERE EXPLANTED. THE EXPLANTED IPG AND LEADS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276510 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 363431 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention