BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 18327505 · Received December 14, 2023

    Report

    Report Number
    3006630150-2023-07848
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    November 27, 2023
    Report Date
    December 14, 2023
    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
    SD, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7082362. PRODUCT FAMILY: SCS-IPG-R-MRI. UPN: M365SC12320. MODEL: SC-1232 SERIAL: (B)(6). BATCH: 566496.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DESPITE REPROGRAMMING. IT WAS NOTED THAT THE LEAD HAD HIGH IMPEDANCES AND PATIENT HAD FALLEN WHICH CAUSED DAMAGE ON THE LEAD. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD AND IPG WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273667 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7082357 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention