BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 8634516 · Received May 22, 2019

    Report

    Report Number
    3006630150-2019-02409
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    May 4, 2019
    Report Date
    May 22, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789567
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2352-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5005418, MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 70 CM. MODEL NUMBER/CATALOG NUMBER: SC-2366-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5072719, MODEL/CATALOG DESCRIPTION: LINEAR 3-6 LEAD 70 CM. MODEL NUMBER/CATALOG NUMBER: SC-1160, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 351639, MODEL/CATALOG DESCRIPTION: SPECTRA WAVEWRITER IPG KIT. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED AN INFECTION. A PINHOLE LIKE WOUND NEAR THE SUTURES OF PATIENTS OCCIPITAL LEAD WAS NOTED ONE WEEK AFTER THE IMPLANT PROCEDURE. THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED AND THE PHYSICIAN BELIEVED THAT FISTULA OR POOR HEALING WAS DUE TO PATIENTS POOR VASCULARITY. ANTIBIOTICS WERE PRESCRIBED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425372 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 5072720 08714729789567

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention