BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3993864 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09100
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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).

    Additional Manufacturer Narrative · 1

    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 THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. ALERT FOR OUT OF RANGE SUBTHRESHOLD LEAD IMPEDANCE ALERT ON (B)(6) 2014. MEASUREMENTS INVOLVING RV COIL (RV TIP-RV COIL, RV RING-RV COIL, RV DEFIB, SVC DEFIB) ALL EXHIBIT INCREASING IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE TRIGGERED AN ALARM DUE TO AN INCREASE IN RIGHT VENTRICULAR (RV) AND SUPERIOR VENA CAVA (SVC) DEFIBRILLATOR LEAD IMPEDANCE VALUES. A CONNECTION ISSUE WAS SUSPECTED, SINCE THE LEAD HAD BEEN IMPLANTED ABOUT FOUR MONTHS EARLIER. SINCE THE PATIENT HAD SEVERE HEART FAILURE, THE PHYSICIAN DECIDE TO TURN OFF THE ALARM AND FOLLOW THE PATIENT CLOSELY. 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
    471194 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944A65

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention D384VRG ICD