BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 4162648 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12665
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 6, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. (B)(4).

    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 OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER), THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WAS TRIGGERED , AND THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. THE ANALYST NOTED THAT BEGINNING (B)(6) 2014, THE SENSING INTEGRITY COUNTS UP TO 3938 WITH MULTIPLE NON-SUSTAINED TACHYCARDIA EPISODES COLLECTED WITH LEAD NOISE OVERSENSING. ON (B)(6) 2014, THE RIGHT VENTRICULAR (RV) LEAD PACING LEAD IMPEDANCE MEASURED 1140 OHMS. THE RV LEAD INTEGRITY ALERT (LIA) OCCURRED ON (B)(6) 2014 FOR SENSING INTEGRITY COUNTER GREATER THAN 30 IN 3 DAYS AND RV LEAD IMPEDANCE VARIATION.

    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 THE LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED FOR THE RIGHT VENTRICULAR (RV) LEAD DUE TO NOISE ON THE RV CHANNEL. DURING FOLLOW UP, THE PHYSICIAN WAS ABLE TO REPRODUCE THE NOISE WITH POCKET MANIPULATION OF THE DEVICE. IN ADDITION, THE PACING THRESHOLD INCREASED TO 3 VOLTS. THE PHYSICIAN ELECTED TO REPROGRAM THE RV LEAD TIP TO COIL AND CONTINUE THE MONITOR THE PATIENT CLOSELY. THE RV 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
    643903 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention D354DRG ICD