BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4-CH DBS EXTENSION KIT, 50CM

    MDR report key: 22291243 · Received June 19, 2025

    Report

    Report Number
    1627487-2025-03050
    Event Type
    Injury
    Date Received
    June 19, 2025
    Date of Event
    May 30, 2025
    Report Date
    July 25, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MHY
    UDI-DI
    05414734403245
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE OF EVENT IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 2 EXTENSIONS; HOWEVER, IT IS UNKNOWN WHICH EXTENSION; THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DBS 4 CHANNEL EXTENSION, MODEL: 6345, UDI: (B)(4), BATCH: 9012971.

    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 · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE EXTENSION SITE. IT IS UNKNOWN WHICH EXTENSION IS AT FAULT. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT EXPERIENCED PAIN AT BOTH EXTENSION SITES. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN BOTH EXTENSIONS WERE EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723354 4-CH DBS EXTENSION KIT, 50CM DBS EXTENSION MHY ABBOTT MEDICAL 6345 9012971 05414734403245

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other DBS EXTENSION| DBS IPG