BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO VR

    MDR report key: 2201922 · Received August 11, 2011

    Report

    Report Number
    6000094-2011-01344
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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. STD REVIEW - LEAD INTEGRITY ALERT TRIGGERED. PROGRAMMER DATA SHOWS A LEAD INTEGRITY ALERT ON (B)(4)-2011 03:00:21. IMPEDANCE - HIGH RESISTANCE/IMPEDANCE, 2 - PATIENT ALERTS FOR RV. PACE LEAD Z>3000 OHMS (B)(4)-2011 03:00:05 AND (B)(4)-2011 03:00:03. WEEKLY PACE MEASUREMENT LOG DATA IN S2D FILE (B)(4) SHOWS AN INCREASE FOR MIN AND MAX V.PACE= 1120 TO 1552 OHMS PEAK BETWEEN (B)(4)-2009 AND (B)(4)-2011. SENSING - INTERFERENCE/NOISE VENTRICULAR SHORT INTERVAL COUNT V-SIC=156.1 COUNTS AVG/DAY, IN 2.1 DAYS, BETWEEN (B)(4)-2011 12:50:37 AND (B)(4)-2011 14:15:56.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CALLER STATED THE LEAD INTEGRITY ALERT TRIPPED. THE DEVICE IS STILL 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 MAXIMO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7232CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other