BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17431539 · Received July 31, 2023

    Report

    Report Number
    1627487-2023-03600
    Event Type
    Injury
    Date Received
    July 31, 2023
    Date of Event
    July 7, 2023
    Report Date
    August 24, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MHY
    UDI-DI
    05415067030337
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENT POTENTIALLY INVOLVED IN THE EVENT INCLUDES: COMMON DEVICE NAME: DBS LEAD, MODEL: 6173, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8844019.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING DIFFICULTY SPEAKING AFTER THE DBS SYSTEM WAS IMPLANTED. THE PATIENT UNDERWENT A REHABILITATION PROGRAM FOLLOWING HOSPITALIZATION TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335813 8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY ABBOTT MEDICAL 6173 8844019 05415067030337

    Patients

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