BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 20545328 · Received October 28, 2024

    Report

    Report Number
    3006630150-2024-07365
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    July 17, 2024
    Report Date
    November 27, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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: 7071008.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A LEAD FRACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A LEAD FRACTURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEADS ALSO HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019926 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-50 7070709 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other| R