BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B

    MDR report key: 11952663 · Received June 7, 2021

    Report

    Report Number
    1627487-2021-14683
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    March 25, 2021
    Report Date
    October 7, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MHY
    UDI-DI
    05415067030337
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THEIR CALF FOLLOWING A LEAD IMPLANT PROCEDURE ON (B)(6) 2021. THE PATIENT WAS DIAGNOSED WITH A DEEP-VEIN THROMBOSIS (DVT). THE PATIENT WAS PRESCRIBED TO WEAR COMPRESSION SOCKS, RESOLVING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846185 8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B DBS LEAD MHY ABBOTT MEDICAL 6173 7699593 05415067030337

    Patients

    Seq Age Sex Outcome Treatment
    1 Other