BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 11141222 · Received January 8, 2021

    Report

    Report Number
    3006630150-2020-06632
    Event Type
    Injury
    Date Received
    January 8, 2021
    Date of Event
    December 16, 2020
    Report Date
    January 8, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: 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: (B)(4), MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 7073326.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PERCUTANEOUS LEADS WERE PLACED CLOSE TO NERVE ROOTS DUE TO HIGH LEVELS OF SCAR TISSUE. THE SYMPTOMS INCLUDED PAIN WITH BURNING SENSATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PERCUTANEOUS LEADS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36273 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5085997 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention