BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 20921193 · Received December 12, 2024

    Report

    Report Number
    3006630150-2024-08704
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 20, 2024
    Report Date
    January 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    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

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6) AND BATCH: 7081338.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS HAD FRACTURED, HOWEVER, THIS WAS NOT CONFIRMED THROUGH IMAGING. NO FURTHER INFORMATION COULD BE OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS HAD FRACTURED, HOWEVER, THIS WAS NOT CONFIRMED THROUGH IMAGING. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2417378 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 7084338 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention