BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 18027062 · Received October 29, 2023

    Report

    Report Number
    3006630150-2023-06620
    Event Type
    Malfunction
    Date Received
    October 29, 2023
    Date of Event
    February 1, 2022
    Report Date
    January 29, 2024
    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
    NE, 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) , BATCH: 5143303.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES. IT WAS ALSO NOTED OF THE LEAD BEING FRACTURED. NO FURTHER ACTION TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES. IT WAS ALSO NOTED OF THE LEAD BEING FRACTURED. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE. THE EXPLANTED LEAD WAS NOT RETURNED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2207743 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5143299 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention