BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8CH INFINITY DBS FLEX EXTN KIT, 50CM, B

    MDR report key: 23830168 · Received December 17, 2025

    Report

    Report Number
    1627487-2025-06214
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    November 11, 2025
    Report Date
    February 17, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MHY
    UDI-DI
    05415067020307
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES WAS NOT CONFIRMED. AS RECEIVED, MICROSCOPIC INSPECTION OF THE LEAD EXTENSION SHOWED NO ANOMALIES AND THE LEAD EXTENSION PASSED ALL FUNCTIONAL TESTING. THE CAUSE OF THE REPORTED EVENT COULD NOT BE ASCERTAINED.

    Additional Manufacturer Narrative · 0

    DATE OF EVEN IT ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 2 EXTENSIONS; HOWEVER, IT IS UNKNOWN WHICH LEAD, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DBS EXTENSION, MODEL: 6371, UDI: (B)(4), SERIAL: (B)(6), BATCH:5924027.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON ONE EXTENSION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE EXTENSION WAS EXPLANTED AND REPLACED. THE INVESTIGATION WAS UNABLE TO DETERMINE THE EXTENSION THAT ASSOCIATED WITH THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039359 8CH INFINITY DBS FLEX EXTN KIT, 50CM, B DBS EXTENSION MHY ABBOTT MEDICAL 6371 5924027 05415067020307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other DBS EXTENSION