BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 5714266 · Received June 9, 2016

    Report

    Report Number
    2649622-2016-07126
    Event Type
    Injury
    Date Received
    June 9, 2016
    Date of Event
    April 5, 2016
    Report Date
    April 5, 2016
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE 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, THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT (LIA) WERE MET, AND OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/ SHORT INTERVAL COUNTS (SIC). ANALYST COMMENTED, 10 NON-SUSTAINED TACHYCARDIA EPISODES WITH V-V INTERVALS GREATER THAN 220 MILLISECONDS ON (B(6) 2016 41 VENTRICULAR SIC SINCE LAST SESSION 8.2 HOURS AGO. LEAD FAILURE PREDICTOR TRIGGERED ON (B)(6) 2016 FOR VENTRICULAR SIC AND NON-SUSTAINED TACHYCARDIA EPISODES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE THE RIGHT VENTRICULAR (RV) LEAD WAS SUSPECTED TO BE FRACTURED. THE ISSUE WAS DETECTED DUE TO AN ALERT THAT REVEALED SHORT INTERVALS AND NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT) EPISODES. A NEW LEAD WAS IMPLANTED. THE RV WAS CAPPED AND REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368305 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R