BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11076308 · Received December 28, 2020

    Report

    Report Number
    3006630150-2020-06422
    Event Type
    Injury
    Date Received
    December 28, 2020
    Date of Event
    December 4, 2020
    Report Date
    December 28, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: (B)(4), MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7043386. PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: (B)(4), MODEL: SC-4316, SERIAL: NA, BATCH: 23254071.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DESPITE SEVERAL REPROGRAMMING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN EVERYTHING WAS REMOVED. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541368 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 347336 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention