BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3616765 · Received February 8, 2014

    Report

    Report Number
    2649622-2014-01407
    Event Type
    Injury
    Date Received
    February 8, 2014
    Date of Event
    November 1, 2013
    Report Date
    December 4, 2013
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL PRODUCT WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND WAS ANALYZED. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/ SENSING INTEGRITY COUNTER (SIC). ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RIGHT VENTRICULAR (RV) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. 2750 VENTRICULAR SHORT INTERVAL COUNTS (V-SIC) OCCUR SINCE (B)(6) 2013. 46 NON-SUSTAINED TACHYCARDIA (NST) AND 4 VF EPISODES OF <(><<)> 220 MS V-V CYCLE ARE RECORDED ON (B)(6) 2013. MAX V-PACE IMPEDANCE RISES FROM AN APPROXIMATE BASELINE OF 650 OHM TO > 2800 OHM THE WEEK ENDING (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SUDDEN DROP IN R-WAVES FROM TIP TO COIL. THE LEAD WAS REPROGRAMMED AND IT 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
    85328 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention