BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3991274 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08197
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 12, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 RIGHT VENTRICULAR (RV) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. ANALYST COMMENTED, RV PACE IMPEDANCE STEADY AT 420 OHMS THROUGH (B)(6) 2014, RISES OUT OF RANGE (GREATER THAN 3000 OHMS) STARTING (B)(6) 2014. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SENSING INTEGRITY COUNTER (SIC). ANALYST COMMENTED, 14 NON SUSTAINED EPISODES WITH V-V INTERVALS LESS THAN 220 MS BETWEEN (B)(6). MULTIPLE NON SUSTAINED EPISODES PER DAY STARTING (B)(6) 2014, AND 154 VENTRICULAR (SIC)/DAY OVER LAST 30 DAYS. LEAD FAILURE PREDICTOR TRIGGERED ON (B)(6) 2014 FOR VENTRICULAR (SIC) AND NON SUSTAINED EPISODES.

    Additional Manufacturer Narrative · 1

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

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD ALERT TRIGGERED FOR HIGH IMPEDANCE AND NOISE. THE RV LEAD SHOCK DETECTIONS WERE PROGRAMMED OFF, AND THE LEAD REMAINED IN USE. FURTHER IT WAS INDICATED THAT THE RV LEAD ENCOUNTERED A SPIKE IN IMPEDANCE, ALONG WITH SHORT INTERVAL COUNTING ISSUE, AND AN APPARENT FRACTURE. SUBSEQUENTLY, THE RV LEAD WAS PARTIALLY EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472799 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| R D294VRG ICD