BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 14856683 · Received June 29, 2022

    Report

    Report Number
    3006630150-2022-03183
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    June 1, 2021
    Report Date
    October 4, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED A YEAR AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(4). BATCH: 5172628.

    Additional Manufacturer Narrative · 0

    THE RETURNED LINEAR LEAD WAS ANALYZED AND IT WAS REPORTED THAT NINE WIRES WERE FRACTURED AT THE CLIK SITE, ABOUT TWENTY-TWO POINT FIVE CENTIMETERS FROM THE DISTAL END. MODEL: SC-2317-50. SN: (B)(6). THE RETURNED LINEAR LEAD WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE STIMULATION COVERAGE DUE TO HIGH IMPEDANCES ON THE LEADS. IT WAS ALSO NOTED THAT THE PATIENT HAD SEVERAL NON-DEVICE RELATED FALLS THAT MAY HAVE CAUSED LEAD MIGRATION AND LEAD FRACTURE. THE PATIENT WILL UNDERGO A LEAD REVISION PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE STIMULATION COVERAGE DUE TO HIGH IMPEDANCES ON THE LEADS. IT WAS ALSO NOTED THAT THE PATIENT HAD SEVERAL NON-DEVICE RELATED FALLS THAT MAY HAVE CAUSED LEAD MIGRATION AND LEAD FRACTURE. THE PATIENT WILL UNDERGO A LEAD REVISION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE STIMULATION COVERAGE DUE TO HIGH IMPEDANCES ON THE LEADS. IT WAS ALSO NOTED THAT THE PATIENT HAD SEVERAL NON-DEVICE RELATED FALLS THAT MAY HAVE CAUSED LEAD MIGRATION AND LEAD FRACTURE. THE PATIENT WILL UNDERGO A LEAD REVISION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090747 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5092382 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention