BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2951805 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00244
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 6, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. PRODUCT EVALUATION SUMMARY: THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS REVEALED THAT A LEAD INTEGRITY ALERT TRIGGERED WITH THE PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(4) 2010. ALSO, THE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE WAS OUT OF RANGE UNDEFINED WITH THE PROGRAMMER DATA SHOWING AN ALERT FOR "RV PACING LEAD IMPEDANCE NOT TAKEN." ON (B)(4) 2012. THERE WAS A PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4) 2012. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD 2009 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT TRIGGERED FOR THE RIGHT VENTRICULAR (RV) LEAD DUE TO SHORT INTERVAL COUNTS (SIC). THERE HAD ALSO BEEN PATIENT ALERTS FOR OUT OF TOLERANCE PACING IMPEDANCE ON THE RV LEAD. THERE WAS EXTENSIVE ISOMETRIC TESTING PERFORMED IN THE CLINIC WHICH RESULTED IN NO OVERSENSING. THE RV LEAD 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
    57586 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR