BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3153267 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05904
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    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: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED AND ANALYSIS REVEALED RIGHT VENTRICULAR (RV) OVERSENSING AND RV TWAVE OVERSENSING. CONCOMITANT PRODUCTS: 4076 IMPLANTABLE PACING LEAD (B)(6) 2011; 4196 IMPLANTABLE PACING LEAD (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT VENTRICULAR LEAD NOISE WARNING AND A RIGHT VENTRICULAR LEAD INTEGRITY ALERT. IT WAS ALSO REPORTED THAT THERE WAS VENTRICULAR TACHYCARDIA/VENTRICULAR FIBRILLATION WITH TWAVE OVERSENSING SEEN IN THE EPISODES. THE LEAD REMAINS 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
    256197 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR D314TRG IMPLANTABLE BIV DEFIBRILLATOR