BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 8667378 · Received June 4, 2019

    Report

    Report Number
    3006630150-2019-02607
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    April 8, 2019
    Report Date
    July 11, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SC-2218-50 (SN: (B)(4)) DEVICE EVALUATION INDICATED THAT THE COMPLAINT OF HIGH IMPEDANCE WAS CONFIRMED. VISUAL INSPECTION FOUND LEAD BODY WAS BENT/KINKED/DAMAGED AT THE CLIK ANCHOR SITE, 1CM FROM THE SET SCREW MARK. X-RAY INSPECTION CONFIRMED MULTIPLE CABLES WERE FRACTURED. THERE ARE NO EXPOSED CABLES AT THE CLIK SITE FRACTURE. THE LEAD BODY GETS KINKED RIGHT AFTER IT EXITS THE CLIK ANCHOR AND IT RESULTED IN THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5062986, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462130 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5059900 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention