BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 12660921 · Received October 19, 2021

    Report

    Report Number
    3006630150-2021-05857
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    August 16, 2021
    Report Date
    October 19, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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)(4), BATCH: 7071790.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS LEADS HAD SIGNIFICANT IMPEDANCES THAT WERE CAUSING THEM TO NOT GIVE SUFFICIENT COVERAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LINEAR LEADS WERE REPLACED WITH A PADDLE LEAD. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE NOT RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555353 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 7071720 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention