BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 9014016 · Received September 12, 2019

    Report

    Report Number
    3006630150-2019-05015
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    August 23, 2019
    Report Date
    September 12, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5013970, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. MODEL NUMBER/CATALOG NUMBER: SC-4318, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 23963182, MODEL/CATALOG DESCRIPTION: CLIK X ANCHOR STERILE KIT. 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 ARE 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 PATIENTS LEADS AND ANCHOR WERE EXPLANTED FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796840 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5013966 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention