BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 8916086 · Received August 21, 2019

    Report

    Report Number
    3006630150-2019-04455
    Event Type
    Injury
    Date Received
    August 21, 2019
    Date of Event
    June 13, 2019
    Report Date
    August 21, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER:SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 16545386, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. MODEL NUMBER/CATALOG NUMBER: SC-2208-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 152409/152782, MODEL/CATALOG DESCRIPTION: ST LINEAR LEAD 50 CM. THE EXPLANTED LEADS WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATE TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710743 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 16923727 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention