BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 10208434 · Received June 29, 2020

    Report

    Report Number
    3006630150-2020-02689
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    May 13, 2020
    Report Date
    August 24, 2020
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SC-2317-70 (SN: (B)(6) DEVICE EVALUATION INDICATED THE ALLEGATION OF DAMAGED LEAD HAS BEEN CONFIRMED. VISUAL (MICROSCOPE) AND X-RAY INSPECTION OF THE LEAD REVEALED THAT MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD. THE BENT/KINKED LOCATION IS 2 CM FROM THE SET SCREW MARK OF THE CLIK X ANCHOR. THERE ARE NO EXPOSED CABLES AT THE CLIK X ANCHOR SITE FRACTURE LOCATION. THE LEAD GOT KINKED AFTER IT EXITS THE CLIK ANCHOR RESULTING IN THE REPORTED COMPLAINT. IT APPEARS THAT THE LEAD WAS EXPOSED TO EXCESSIVE MECHANICAL FORCE OR MOVEMENT CAUSING THE CABLE FRACTURES RIGHT AT THE ANCHOR POINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS NO LONGER GETTING ADEQUATE THERAPY AND HAD LOST COVERAGE. UPON IMPEDANCE CHECK, SEVERAL CONTACTS NOTED ON THE RIGHT AND LEFT LEADS. THE PATIENT WAS REPROGRAMMED AND WAS ABLE TO REGAIN STIMULATION. IT WAS ALSO FOUND OUT THAT THE LEADS WERE FRACTURED AND WERE REVISED AND RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 5100618.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS NO LONGER GETTING ADEQUATE THERAPY AND HAD LOST COVERAGE. UPON IMPEDANCE CHECK, SEVERAL CONTACTS NOTED ON THE RIGHT AND LEFT LEADS. THE PATIENT WAS REPROGRAMMED AND WAS ABLE TO REGAIN STIMULATION. IT WAS ALSO FOUND OUT THAT THE LEADS WERE FRACTURED AND WERE REVISED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670898 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5098960 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention