BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 17653879 · Received August 30, 2023

    Report

    Report Number
    3006630150-2023-05190
    Event Type
    Injury
    Date Received
    August 30, 2023
    Date of Event
    August 9, 2023
    Report Date
    August 30, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: 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)(6), BATCH: 5081494, 5092999. PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318, BATCH: 22630393.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE LOCATION IS OVER THE INCISION SITE. IT WAS NOTED THAT THE LEADS ERODED THROUGH THE SKIN. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE WHEREIN THE IPG, LEADS, AND CLICK ANCHORS WERE REMOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE EXPLANTED PRODUCT WAS DISCARDED PER FACILITY PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397896 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 343454 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention