BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2952594 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00634
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 19, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    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. PRODUCT EVENT SUMMARY (B)(4) PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. THE SAVE TO DISK PRIMARY RESULT NOTED THE LEAD IMPEDANCE FOR PACING RV WAS OUT OF RANGE HIGH. TWO PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE (B)(6) 2012. WEEKLY PACE LEAD TREND DATA SHOW VARIOUS SPIKE INCREASES FOR MAX RV PACE= 456 TO 2496 OHMS RANGE BETWEEN (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR HIGH AND INTERMITTENT IMPEDANCE DUE TO A SUSPECTED FRACTURE. THE LEAD WAS CAPPED AND WAS REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55492 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC