BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 3152427 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06815
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    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. 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. IT WAS FURTHER NOTED THAT A PATIENT ALERT FOR SVC LEAD IMPEDANCE GREATER THAN 200 OHMS WAS TRIGGERED ON (B)(6) 2012. THE WEEKLY HIGH VOLTAGE TREND DATA SHOWS AN INCREASE FOR RIGHT VENTRICULAR PACING IMPEDANCE EQUAL TO 61 TO 3,584 OHMS RANGE BETWEEN (B)(4) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH AND INCONSISTENT SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE OBSERVED IN THE RIGHT VENTRICULAR (RV) LEAD. THE SVC COIL OF THE RV LEAD WAS PROGRAMMED OFF AND 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
    253012 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6945-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R 7288 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)