BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 15904651 · Received December 2, 2022

    Report

    Report Number
    3006630150-2022-06697
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    February 25, 2022
    Report Date
    March 6, 2023
    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
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7071930.

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED 2 WEEKS AGO FROM DATE MANUFACTURER WAS MADE AWARE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS WERE FRACTURED. IT WAS ALSO NOTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO LEADS HAVING HIGH IMPEDANCES. ADDITIONAL INFORMATION WAS RECEIVED THAT LEAD FRACTURE WAS NOT CONFIRMED THROUGH X-RAY. 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 PATIENTS LEADS WERE FRACTURED. IT WAS ALSO NOTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO LEADS HAVING HIGH IMPEDANCES. ADDITIONAL INFORMATION WAS RECEIVED THAT LEAD FRACTURE WAS NOT CONFIRMED THROUGH X-RAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS WERE FRACTURED. IT WAS ALSO NOTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO LEADS HAD HIGH IMPEDANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796609 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7070508 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention