BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 8580377 · Received May 3, 2019

    Report

    Report Number
    3006630150-2019-02060
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    March 19, 2019
    Report Date
    June 27, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXPLANTED LEADS WERE NOT RETURNED TO BSN.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT HAD INADEQUATE STIMULATION AS THE COVERAGE HAD CHANGED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE PER PHYSICIANS PREFERENCE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5082830, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD INADEQUATE STIMULATION AS THE COVERAGE HAD CHANGED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE PER PHYSICIANS PREFERENCE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372774 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5082684 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention