BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT

    MDR report key: 3992492 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09861
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    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) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. MAXIMUM PACE IMPEDANCE RISES FROM 864 OHMS THE WEEK ENDING (B)(4) 2014 TO GREATER THAN 4000 OHMS THE WEEK ENDING (B)(4) 2014. ANALYSIS OF THE DEVICE MEMORY INDICATED A LEAD IMPEDANCE OUT OF RANGE ALERT. AN OUT OF TREND SUBTHRESHOLD LEAD IMPEDANCE ALERT OCCURRED ON (B)(4) 2014. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). 643 OF 18005 LIFETIME VENTRICULAR SIC ARE RECORDED BEGINNING (B)(4) 2014. LEAD INTEGRITY ALERT (LIA) TRIGGERED ON (B)(4) 2010 DUE TO MEETING THE REQUIREMENTS FOR NON-SUSTAINED TACHYCARDIA (NST) AND VENTRICULAR SIC. THERE ARE ELEVEN NST EVENTS OF LESS THAN 220 MS V-V CYCLE RECORDED BETWEEN (B)(4) 2014.

    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. CONCOMITANT PRODUCT: D234VRC, ICD. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SINGLE HIGH IMPEDANCE COUNT OCCURRED WITH THE RIGHT VENTRICULAR (RV) LEAD. NOISE WAS ALSO NOTED ON THE RV LEAD. THE RV LEAD REMAINS IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468189 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6943

    Patients

    Seq Age Sex Outcome Treatment
    1 1056K, ST. JUDE MEDICAL LEAD