BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA

    MDR report key: 1991002 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00814
    Event Type
    Injury
    Date Received
    February 15, 2011
    Report Date
    July 16, 2013
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    Z-0111-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT INDICATES THAT LEAD HAS BEEN "TUNED" SO THAT IT DOES NOT HAPPEN. THE LEAD AND DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DOES NOT GET HEART RATE UP ENOUGH WITH NORMAL WALKING ACTIVITIES. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. IT WAS FURTHER REPORTED BY THE PATIENT THAT THEY THOUGHT THEIR LEFT VENTRICLE HAD BEEN OVER PACED FOR YEARS WHICH DAMAGED THE VENTRICLE AND THE PATIENT'S EJECTION FRACTION. THE PATIENT ALSO REPORTED THAT SINCE THE DEVICE WAS REPROGRAMMED THEY HAD FELT BETTER, BUT IT HAD BEEN "DE-TUNED" AND THE PATIENT IS NOW EXPERIENCING "VISION DISTURBANCES", "EYE ACHES" AND "PRESSURE" IN HEAD. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DOES NOT GET HEART RATE UP ENOUGH WITH NORMAL WALKING ACTIVITIES. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. IT WAS FURTHER REPORTED BY THE PATIENT THAT THEY THOUGHT THEIR LEFT VENTRICLE HAD BEEN OVER PACED FOR YEARS WHICH DAMAGED THE VENTRICLE AND THE PATIENT'S EJECTION FRACTION. THE PATIENT ALSO REPORTED THAT SINCE THE DEVICE WAS REPROGRAMMED THEY HAD FELT BETTER, BUT IT HAD BEEN "DE-TUNED" AND THE PATIENT IS NOW EXPERIENCING "VISION DISTURBANCES", "EYE ACHES" AND "PRESSURE" IN HEAD. THE DEVICE REMAINS IN USE. THE PATIENT LATER REPORTED THAT THE DEVICE WAS SET TOO HIGH AND THE PATIENT WAS OVER PACED FOR A PERIOD OF TIME, BUT THE DEVICE IS NOW SO LOW THAT THE PATIENT CAN "HARDLY FUNCTION". THE PATIENT ALSO STATED THAT ONE OF THE LEADS WAS IN THE WRONG PLACE AND STIMULATES THE PATIENT'S DIAPHRAGM.

    Description of Event or Problem · 1

    THE PATIENT FURTHER REPORTED NOW HAVING PACEMAKER SYNDROME.

    Description of Event or Problem · 1

    THE PATIENT FURTHER REPORTED THAT SINCE THE DEVICE OPTIMIZATION THE PATIENT HAS BEEN SHORT OF BREATH AND HAD A HEART RATE OF 112.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DOES NOT GET HEART RATE UP ENOUGH WITH NORMAL WALKING ACTIVITIES. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD| 4195 IMPLANTABLE PACING LEAD| 4195 IMPLANTABLE PACING LEAD