BEUDAMED
    FDA Adverse Event Summary report: N

    MICRO-PACE

    MDR report key: 2779592 · Received October 3, 2012

    Report

    Report Number
    1218087-2012-00058
    Date Received
    October 3, 2012
    Report Date
    June 28, 2012
    Manufacturer
    PACE MEDICAL, INC.
    Product Code
    JOQ
    PMA / PMN Number
    P920032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PACE MEDICAL HAS NO DATA TO PROCEED WITH REGARDING THIS ALLEGED INCIDENT. ONLY ANECDOTAL INFO IS SUPPLIED BY THE USER. PACE MEDICAL HAS REQUESTED ADDITIONAL DATA AND IT APPEARS THE USER CANNOT PROVIDE ANY ADDITIONAL INFO AND APPEARS TO BELIEVE THE EVENTS ARE NOT RELATED. IT IS OUR OPINION THE AAI PACING DOES NOT PRECIPITATE VF. PACE MEDICAL WILL CONTINUE TO MONITOR THIS SITUATION AND REPORT AS REQUIRED.

    Description of Event or Problem · 1

    DEAR (B)(6), WE ARE NOT GOING TO BE ABLE TO GET THE SERIAL NUMBER AS IT WAS NOT RECORDED AND I AM ALSO ALMOST SURE THAT IT WAS NOT A PACEMAKER RELATED PROBLEM. I REPORTED AS, PER OUR AGREEMENT JUST IN CASE. THERE IS STILL A LACK OF CONFIDENCE IN THE 4580 AND I AM TRYING TO GET PEOPLE TO LOOK AT THIS RATIONALLY AND GIVE THEM A SECOND (OR SHOULD I SAY 3RD) TRIAL AS WE DISCUSSED. I HAVE NOW INSTIGATED A PHYSIOLOGIST WARD ROUND EACH MORNING TO CHECK PACING AND SENSING ON ANY 4580S ON PTS. THANKS FOR YOUR PROMPT RESPONSE. KIND REGARDS, (B)(6). DEAR (B)(6), I HAD ANOTHER INCIDENT REPORTED AT THE WEEKEND OF UNDER-SENSING ON ONE OF THE ABOVE BOXES. THIS WAS LINKED TO A PT GOING INTO VF AND SUBSEQUENTLY DYING. THE WHOLE EPISODE IS UNCLEAR AND THE CCITU DID NOT ISOLATE THE BOX NOT REPORT THE INCIDENT PROPERLY; THEREFORE, WE HAVE NO WAY TO KNOWING WHETHER THIS WAS A REAL ISSUE OR NOT. FROM AN OBSERVATION, IT WAS PREVIOUSLY UNDERSENSING IN AAI MODE WHICH I DON NOT THINK IS AN ISSUE AS ATRIAL WIRES ARE NOTORIOUSLY BAD FOR SENSING. I AM AWAITING A CLEARER EXPLANATION OF WHAT HAPPENED AND ALSO FOR THE PT'S NOTES SO I CAN SEE WHAT IS DOCUMENTED BUT I AM SLIGHTLY CONCERNED THAT THIS COULD BE A REPEAT. IF SO, WE WILL HAVE TO WITHDRAW THE WHOLE BATCH OF THEM AGAIN. I WILL KEEP YOU UPDATED WHEN I HAVE MORE INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-PACE TEMPORARY CARDIAC PACEMAKER JOQ PACE MEDICAL, INC. 4580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other