BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II VR

    MDR report key: 2791132 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02194
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    Z-0114-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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. SENSING - OVERSENSING: THERE WERE THIRTEEN VENTRICULAR NST<=210 MS BETWEEN (B)(6) 2012 02:58:48 AND (B)(6) 2012 12:14:32. SENSING - INTERFERENCE/NOISE: VENTRICULAR SHORT INTERVAL COUNT V-SIC=287.5 COUNTS AVG/DAY, IN 58.11 DAYS, BETWEEN (B)(6) 2012 10:26:30 AND (B)(6) 2012 13:00:55. EVALUATION SUMMARY (B)(4): THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD LOW R-WAVES. THEREFORE THE PACE/SENSE PORTION OF THE RV LEAD WAS CAPPED AND REPLACED WITH A NEW PACE/SENSE LEAD. THE HIGH VOLTAGE PORTION OR THE RV LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT IT WAS DISCOVERED THAT THE NEW PACE/SENSE LEAD WASN'T PROPERLY PLACED IN THE RV PORT OF THE DEVICE AND THAT IT WAS IMPOSSIBLE TO PULL THE NEW PACE/SENSE LEAD OUT OF THE RV PORT. THEREFORE THE DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE. 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 II VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D284VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R SR60 COMPETITOR IMPLANTABLE PACING LEAD