BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN¿ CRANIAL BURR HOLE COVER SYSTEM

    MDR report key: 17805242 · Received September 24, 2023

    Report

    Report Number
    1627487-2023-04550
    Event Type
    Injury
    Date Received
    September 24, 2023
    Date of Event
    September 1, 2023
    Report Date
    November 28, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MHY
    UDI-DI
    05415067030283
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. THE ALLEGATION IS AGAINST ONE OF TWO BURR HOLE COVERS; HOWEVER, IT IS UNKNOWN WHICH BURR HOLE COVER(S), THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS, MODEL: 6010, UDI: (B)(4), BATCH: 8944072. THE ALLEGATION IS AGAINST ONE OF TWO DBS LEADS; HOWEVER, IT IS UNKNOWN WHICH BURR HOLE COVER(S), THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS, MODEL: 6173, UDI: (B)(4), SERIAL NUMBER: (B)(6), BATCH: 8533144.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATES THE WOUND IS HEALING BUT NOT COMPLETELY CLOSED.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-04551. IT WAS REPORTED THE PATIENT EXPERIENCED WOUND EROSION AT THE BURR HOLE SITE. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE BURR HOLE WAS REMOVED, WASHED OUT AND THE INCISION WAS CLOSED. THE LEAD WAS LEFT IN PLACE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE BURR HOLE COVERS OR LEADS ATTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295558 GUARDIAN¿ CRANIAL BURR HOLE COVER SYSTEM DBS BURR HOLE COVER MHY ABBOTT MEDICAL 6010 8904715 05415067030283

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other DBS BURR HOLE COVER| DBS EXTENSIONS X 2| DBS IPG| DBS LEAD