BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3152578 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06759
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING ASSOCIATED WITH THE RIGHT VENTRICULAR LEAD. THERE WERE ELEVEN VENTRICULAR NON SUSTAINED TACHYCARDIA (NST) EPISODES LESS THAN OR EQUAL TO 210 MS (MILLISECONDS) BETWEEN (B)(6) 2012 AND (B)(6) 2013. THERE WAS ALSO ONE VENTRICULAR FIBRILLATION (VF) EPISODE EQUAL TO 160 MS AVERAGE VENTRICULAR CYCLE ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE NON-SUSTAINED TACHYCARDIA (NST'S) AND SHORT V-V INTERVALS. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252756 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R