BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 19075747 · Received April 9, 2024

    Report

    Report Number
    1627487-2024-08013
    Event Type
    Death
    Date Received
    April 9, 2024
    Date of Event
    March 14, 2024
    Report Date
    August 28, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MHY
    UDI-DI
    05415067030320
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PATIENT DEATH WAS REPORTED TO ABBOTT. THE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN. ADDITIONALLY, NO SYSTEM COMPLAINTS WERE REPORTED NOR WERE IMPLANTED PRODUCTS RETURNED FOR ANALYSIS. ALL EVENT INFORMATION PERTAINING TO THIS DEVICE HAS BEEN REVIEWED AND NO PRODUCT INVESTIGATION IS NECESSARY AT THIS TIME AS THE CIRCUMSTANCES OF THE EVENT HAVE NOT BEEN ATTRIBUTED TO THE IMPLANTED SYSTEM. ADDITIONALLY, THE DEVICE HISTORY RECORD OF THE DEVICE WAS REVIEWED TO CONFIRM THAT ALL MANUFACTURING STEPS WERE COMPLETED AND THERE WERE NO NON-CONFORMANCES NOTED THAT COULD HAVE CONTRIBUTED TO THIS ISSUE.

    Additional Manufacturer Narrative · 0

    A PATIENT DEATH WAS REPORTED TO ABBOTT. THE PATIENT DIED AT HOME 8 DAYS AFTER THE PROCEDURE WITH ABBOTT COMPONENTS IMPLANTED. BASED ON THE MEDICAL REVIEW OF AUTOPSY, IT HAS BEEN CONFIRMED THAT THE DEATH WAS A CARDIAC ARREST AND IS UNRELATED TO ABBOT DEVICES OR THE DBS PROCEDURE. ADDITIONALLY, THE DEVICE HISTORY RECORD OF THE DEVICE WAS REVIEWED TO CONFIRM THAT ALL MANUFACTURING STEPS WERE COMPLETED AND THERE WERE NO NON-CONFORMANCES NOTED THAT COULD HAVE CONTRIBUTED TO THIS ISSUE.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE NUMBER: (B)(6).

    Description of Event or Problem · 0

    BASED ON THE MEDICAL REVIEW OF AUTOPSY, IT HAS BEEN CONFIRMED THAT THE DEATH WAS A CARDIAC ARREST AND IS UNRELATED TO ABBOT DEVICES OR THE DBS PROCEDURE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED DETERMINED THE CAUSE OF DEATH WAS CARDIO-RESPIRATORY ARREST.

    Description of Event or Problem · 0

    ABBOTT WAS NOTIFIED ON 19 MAR 2024, THAT A PATIENT IN BRAZIL PASSED AWAY POST DBS IMPLANT ON (B)(6) 2024, DUE TO UNKNOWN CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. WE WILL PROVIDE AN UPDATED REPORT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540326 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B DBS LEAD MHY ABBOTT MEDICAL 6172 10016349 05415067030320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| D