BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 12668619 · Received October 20, 2021

    Report

    Report Number
    3006630150-2021-05889
    Event Type
    Injury
    Date Received
    October 20, 2021
    Date of Event
    September 28, 2021
    Report Date
    December 24, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SC-1160 SN: (B)(4). THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. SC-2218-50 SN: (B)(4). THE RETURNED LEAD WAS ANALYZED AND VISUAL INSPECTION REVEALED THAT THE LEAD WAS CLEANLY CUT APPROXIMATELY 23.5 CM FROM THE PROXIMAL END OF THE LEAD AND THE DISTAL PORTIONS OF THE LEAD WAS NOT RETURNED. THE CLEAN-CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. NO OTHER ANOMALIES WERE IDENTIFIED ON THE RETURNED PORTION OF THE LEAD. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES: THE REPORTED EVENT WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IPG WAS CAUSING SHOCK. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    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-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH/LOT: 7072332/ 7073714.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS IPG WAS CAUSING SHOCK. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564823 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 361325 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention