BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 19084739 · Received April 10, 2024

    Report

    Report Number
    3006630150-2024-02262
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    January 1, 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
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN JANUARY 2024, ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70 , SERIAL: (B)(6), BATCH: 5173112.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED AN ELECTRIC SHOCK A FEW MONTHS AGO FROM A NON-BOSTON SCIENTIFIC DEVICE. ADDITIONALLY, HIGH IMPEDANCES WERE DISCOVERED ON THE LEADS. THEREFORE, THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE DURING WHICH THE LEADS WERE EXPLANTED AND REPLACED. THE PATIENT HAD FULLY RECOVERED POST OPERATIVELY. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023238 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5173113 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention