BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 9988371 · Received April 22, 2020

    Report

    Report Number
    3006630150-2020-01860
    Event Type
    Injury
    Date Received
    April 22, 2020
    Date of Event
    April 3, 2020
    Report Date
    April 22, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/ CATALOG NUMBER: SC-4316, BATCH/ LOT NUMBER: 24474883, MODEL/ CATALOG DESCRIPTION: CLIK ANCHOR. MODEL NUMBER/ CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/ LOT NUMBER: 7072376, MODEL/ CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS LEADS WERE EXPOSED DUE TO IMPROPER WOUND HEALING. THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450484 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7072375 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention