BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3993383 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09336
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THE IMPEDANCE ON THE SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. THE SVC DEFIB IMPEDANCE WAS STEADY AT ~50 OHMS THROUGH (B)(6) 2014 THEN RISES OUT OF RANGE (>250 OHMS) STARTING (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE SVC COIL WAS PROGRAMMED OFF.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PACING IMPEDANCE WAS HIGH AND A FRACTURE WAS CONFIRMED. THE DEVICE WAS PROGRAMMED OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SVC COIL ON THE RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND AN INTEGRITY ISSUE WAS NOT CONSISTENTLY DETERMINED. THE LEAD WAS NOTED TO BE FULLY INSERTED. 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
    469062 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R