BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 15442816 · Received September 16, 2022

    Report

    Report Number
    3006630150-2022-04834
    Event Type
    Injury
    Date Received
    September 16, 2022
    Date of Event
    August 1, 2021
    Report Date
    October 12, 2022
    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
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: (B)(4). MODEL: SC-2218-50. SERIAL: (B)(4). BATCH: 5061952.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS SHOWED SEVERAL OF THE CONTACTS WERE OUT DUE TO HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS SHOWED SEVERAL OF THE CONTACTS WERE OUT DUE TO HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE AND DOING WELL POST OPERATIVELY. THE EXPLANTED PRODUCT WAS DISCARDED BY THE FACILITY. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION COVERAGE DUE TO HIGH IMPEDANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126836 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5060874 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention