BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR ST

    MDR report key: 7737597 · Received July 31, 2018

    Report

    Report Number
    3006630150-2018-60436
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    August 25, 2017
    Report Date
    September 6, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2208-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 170124, MODEL/CATALOG DESCRIPTION: ST LINEAR LEAD 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2208-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 170124, MODEL/CATALOG DESCRIPTION: ST LINEAR LEAD 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD HIGH IMPEDANCES ON THE RIGHT LEAD DUE TO A POSSIBLE LEAD FRACTURE. MIGRATION ON THE LEFT LEAD WAS ALSO NOTED. THE PATIENT WILL UNDERGO A REPLACEMENT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD HIGH IMPEDANCES ON THE RIGHT LEAD DUE TO A POSSIBLE LEAD FRACTURE. MIGRATION ON THE LEFT LEAD WAS ALSO NOTED. THE PATIENT WILL UNDERGO A REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579326 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2208-50 170062

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR