BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA DR

    MDR report key: 1863204 · Received October 9, 2010

    Report

    Report Number
    6000144-2010-05105
    Event Type
    Malfunction
    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
    US
    Reporter Occupation
    OTHER

    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. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE PACING MODE ON BOTH SIDES OF THE MS MARKER IS DDIR, CAUSING THE AS-VP INTERVALS TO VARY. ALL 8 EPISODES WITH RECORDING (MARKER/EGM) ARE THIS WAY. THE PACING MODE APPEARS STUCK IN DDIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE VARIABLE AV INTERVALS PRIOR TO A MODE SWITCH EPISODE WHILE SEARCH AV WAS NOT PROGRAMMED ON. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. UPDATE; (B)(6) 2010, IT WAS REPORTED THAT BASED ON A REVIEW OF THE SAVE TO DISK ((B)(4)) FILES, THE DEVICE APPEARS TO BE STUCK IN DDIR MODE, EVEN THOUGH THE PROGRAMMER REPORTED THAT IT IS IN DDDR MODE. NO ADDITIONAL PATIENT HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. VEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other 5554 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD