BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 19078151 · Received April 10, 2024

    Report

    Report Number
    3006630150-2024-02210
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    March 8, 2024
    Report Date
    April 10, 2024
    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
    LA, 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:(B)(4). MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7080594.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF COVERAGE. THE PATIENT UNDERWENT REVISION PROCEDURE WHEREIN PHYSICIAN REPLACED THE PERCUTANEOUS LEADS WITH A PADDLE. WHILE THE ORIGINAL LEADS WERE COMING OUT THREE CONTACTS WERE SCRAPED OFF. THE PHYSICIAN TRIED TO FISH THEM OUT BUT COULD NOT, SO THEY ARE STILL IMPLANTED IN THE PATIENTS BODY. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412123 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7080538 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention