BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 12648215 · Received October 18, 2021

    Report

    Report Number
    3006630150-2021-05831
    Event Type
    Injury
    Date Received
    October 18, 2021
    Date of Event
    July 30, 2021
    Report Date
    December 30, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SC-2317-70 SN: (B)(6). THE RETURNED DEVICE WAS ANALYZED AND THE REPORTED EVENT WAS CONFIRMED. BASED ON A REVIEW OF ALL AVAILABLE INFORMATION CONTACTS ON THE PATIENT'S LEAD WERE OUT. ALL CABLES WERE FRACTURED AT THE CLICK SITE, ABOUT 20.5 CENTIMETERS FROM THE DISTAL END. WHEN EXCESSIVE MECHANICAL OR TENSILE FORCE WAS EXERTED ONTO THE LEAD, THE LEAD GOT KINKED AFTER IT EXITS THE CLIK ANCHOR RESULTING IN THE CABLE FRACTURES, WHICH CAUSED THE REPORTED PATIENTS EXPERIENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT COULD NO LONGER FEEL THE STIMULATION, DESPITE REPROGRAMMING ATTEMPT. PATIENTS LEADS WERE COMPLETELY OUT EXCEPT FOR THREE FUNCTIONING CONTACTS ON LEFT LEAD. THE PATIENT WAS ABLE TO REGAIN COVERAGE UTILIZING THE FUNCTIONAL CONTACTS WITH A LOW STIMULATION RUNNING, AS PATIENT WOULD GET A SHARP PAIN WHEN TURNED UP HIGHER. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED 4 WEEKS AGO FROM THE APPOINTMENT DATE (B)(6) 2021. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 7073488,

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD NO LONGER FEEL THE STIMULATION, DESPITE REPROGRAMMING ATTEMPT. PATIENTS LEADS WERE COMPLETELY OUT EXCEPT FOR THREE FUNCTIONING CONTACTS ON LEFT LEAD. THE PATIENT WAS ABLE TO REGAIN COVERAGE UTILIZING THE FUNCTIONAL CONTACTS WITH A LOW STIMULATION RUNNING, AS PATIENT WOULD GET A SHARP PAIN WHEN TURNED UP HIGHER. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545022 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7072692 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention