BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 18264633 · Received December 5, 2023

    Report

    Report Number
    3006630150-2023-07598
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    June 10, 2020
    Report Date
    December 29, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: M365SC2317700 . MODEL: SSC-2317-70 . SERIAL: (B)(6). BATCH: 5102608.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE PATIENTS LEADS HAD FRACTURED. THIS WAS NOT CONFIRMED THROUGH IMAGING. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE PATIENTS LEADS HAD FRACTURED. MALFUNCTION WAS NOT CONFIRMED THROUGH IMAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065151 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5099646 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention| O