BEUDAMED
    FDA Adverse Event Summary report: N

    VERSA DR

    MDR report key: 1863227 · Received October 9, 2010

    Report

    Report Number
    6000144-2010-05114
    Date Received
    October 9, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED THAT MODESWITCH ALGORITHM WAS POSSIBLY IN THE PMOP (POST MODESWITCH OVERDRIVE PACING) STATE WHEN THE 30 SECOND COLLECTION DELAY ENDED, SO THE EPISODE WAS NOT LOGGED. THE UNLOGGED EPISODE THEN LIKELY CONTINUED UNTIL THE NEXT FOLLOW-UP. THERE MAY HAVE BEEN BRIEF PERIODS WHERE THE AT/AF TERMINATED, BUT BECAUSE OF PMOP, ANY DURATION LESS THAN 10 MINUTES WOULD MAINTAIN THE CURRENT MODESWITCH EPISODE. IN ORDER FOR THE DIAGNOSTICS TO DETECT A NEW MODESWITCH EPISODE, THE AT/AF NEEDED TO BE TERMINATED FOR 10 MINUTES OR MORE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE DEVICE HAD UNDERGONE 8 MODE SWITCH EPISODES ALL OF WHICH WERE UNDER A MINUTE LONG. THE ATRIAL HISTOGRAM HAD 30% OF THE BEATS IN THE 180-190 RATE BIN, YET NO ATRIAL HIGH RATE (AHR) EPISODES WERE RECORDED. THE ARRHYTHMIA SUMMARY WAS ALSO BLANK, OR SHOWED VERY MINIMAL TIME IN MODE SWITCH. UPON CLEARING AND RE-INTERROGATING THE DEVICE, THERE WAS A RECORDED AHR EPISODE THAT WAS ABOUT 60 SECONDS LONG. THE COMPLAINANT INQUIRED WHY PRIOR AHR EPISODES WERE NOT RECORDED. IT WAS NOTED THAT MODE SWITCH WAS SET TO 175 WITH NO DELAY, ATRIAL CAPTURE MANAGEMENT HAD NOT RUN FOR 2 WEEKS, AND VENTRICULAR CAPTURE MANAGEMENT HAD RUN THE PREVIOUS DAY. THE DEVICE 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 VERSA DR ASKU NVZ MEDTRONIC MED REL, INC. VEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 5076-1 IMPLANTABLE PACING LEAD| 5076-2 IMPLANTABLE PACING LEAD| 5076-1 IMPLANTABLE PACING LEAD| 5076-2 IMPLANTABLE PACING LEAD