BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 10197169 · Received June 25, 2020

    Report

    Report Number
    3006630150-2020-02633
    Event Type
    Injury
    Date Received
    June 25, 2020
    Date of Event
    April 29, 2020
    Report Date
    June 25, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2020. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 7071239.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SMALL AREA OF NONHEALING WOUND IN THE CAUDAL REGION WITH A MINIMAL DRAINAGE. DUE TO POTENTIAL FOR INFECTION WITH THE VERY SMALL PERSISTENT WOUND, BACTRIM WILL BE CONTINUED UNTIL THIS HAS COMPLETELY CLOSED. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE. THE EXPLANTED LEADS WERE NOT RETURNED AS THEY WERE DISPOSED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658362 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 7071236 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention