BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B

    MDR report key: 19554546 · Received June 17, 2024

    Report

    Report Number
    1627487-2024-09145
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    May 24, 2024
    Report Date
    August 2, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MHY
    UDI-DI
    05415067020680
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. SYSTEM DIAGNOSTIC RECORDED LOW IMPEDANCES. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    REPORTER PHONE NUMBER (B)(6). DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DBS LEAD, MODEL: 6172, UDI: (B)(4), SERIAL: (B)(6) LOT: 6141672.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. SYSTEM DIAGNOSTIC RECORDED LOW IMPEDANCES. SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT WAS ASSOCIATED WITH THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650720 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B DBS LEAD MHY ABBOTT MEDICAL 6172 6244858 05415067020680

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other DBS IPG| DBS LEAD