BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 22342590 · Received June 26, 2025

    Report

    Report Number
    1627487-2025-03201
    Event Type
    Injury
    Date Received
    June 26, 2025
    Date of Event
    January 19, 2024
    Report Date
    June 26, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MHY
    UDI-DI
    05415067030337
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DBS LEAD, MODEL: 6173, UDI: (B)(4), SERIAL: (B)(6), BATCH: 6974899. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING EXPLANT PROCEDURE ON (B)(6) 2024 [RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-06059] A SMALL SEGMENT OF THE LEAD REMAINS IMPLANTED. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO REMOVE REMAINING PORTION OF THE LEAD. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT IS ASSOCIATED WITH THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939249 8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B DBS LEAD MHY ABBOTT MEDICAL 6173 6974899 05415067030337

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other DBS BURR HOLE CAP (X2)| DBS EXTENSION (X2)| DBS IPG| DBS LEAD