BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT

    MDR report key: 3153054 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05796
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    January 22, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    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: THE ACTUAL PRODUCT WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND ANALYZED THE DATA. THE SAVE TO DISK PRIMARY FINDING NOTED LEAD IMPEDANCE FOR THE PACING RV WAS OUT OF RANGE HIGH. PERIODICALLY, THE MAX RV PACE IMPEDANCE RISES TO HIGHER THAN 1000 OHMS. THIS OCCURS 10 TIMES TOTAL BETWEEN (B)(6) 2011 AND (B)(6) 2013. THE LEAD IMPEDANCE FOR PACING RV WAS OUT OF RANGE VARYING. THE LEAD INTEGRITY ALERTED FOR IMPEDANCE OUT OF RANGE. AN OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ALERT WAS RECORDED ON (B)(6) 2011, (B)(6) 2012, AND (B)(6) 2013. CONCOMITANT PRODUCTS: D164AWG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD).  (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR FLUCTUATING PACING IMPEDANCES, OVERSENSING, AND NOISE. THE LEAD REMAINS IN USE, BUT REPLACEMENT OF THE LEAD WAS RECOMMENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256203 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6942

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR