BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR ST

    MDR report key: 17000759 · Received May 25, 2023

    Report

    Report Number
    3006630150-2023-02948
    Event Type
    Malfunction
    Date Received
    May 25, 2023
    Date of Event
    May 8, 2022
    Report Date
    August 17, 2023
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED A YEAR AGO FROM DATE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 5152004.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WIRES WERE BROKEN. IT WAS ALSO STATED THAT THE PATIENTS LEAD HAS BECOME DISCONNECTED FROM THE IPG. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT WAS HAVING HIGH IMPEDANCES ON THE LEAD. IT WAS ALSO REPORTED THAT IT HAS NOT YET BEEN CONFIRMED IF THE LEAD IS FRACTURED OR IF THE LEAD SIMPLY WAS NOT PROPERLY SECURED IN THE IPG HEADER DURING THE PATIENTS LAST PROCEDURE. IMAGING WAS TAKEN AND APPEARED THAT THE WIRES HAVE NOT BEEN TAKEN OF THE LEAD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WIRES WERE BROKEN. IT WAS ALSO STATED THAT THE PATIENTS LEAD HAS BECOME DISCONNECTED FROM THE IPG. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT WAS HAVING HIGH IMPEDANCES ON THE LEAD. IT WAS ALSO REPORTED THAT IT HAS NOT YET BEEN CONFIRMED IF THE LEAD IS FRACTURED OR IF THE LEAD SIMPLY WAS NOT PROPERLY SECURED IN THE IPG HEADER DURING THE PATIENTS LAST PROCEDURE. IMAGING OF THE LEAD HAD NOT BEEN TAKEN. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WIRES WERE BROKEN. IT WAS ALSO STATED THAT THE PATIENTS LEAD HAS BECOME DISCONNECTED FROM THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808114 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5151989 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention