BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3614621 · Received February 8, 2014

    Report

    Report Number
    2649622-2014-00398
    Event Type
    Injury
    Date Received
    February 8, 2014
    Report Date
    November 6, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    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. (B)(4).

    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, THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET, AND INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). 3 NON-SUSTAINED TACHYCARDIA AND 5 "LEAD FAILURE PREDICTOR" EPISODES OF LESS THAN 220 MS CYCLE LENGTH ARE RECORDED BETWEEN (B)(6) 2013. 941 LIFETIME V-SIC OCCUR SINCE (B)(6) 2013. LEAD INTEGRITY ALERT (LIA) TRIGGERED ON (B)(6) 2013 DUE TO MEETING THE CONDITIONS FOR NON-SUSTAINED TACHYCARDIA AND V-SIC. MAXIMUM VENTRICULAR PACE IMPEDANCE RISES FROM AN APPROXIMATE BASELINE OF 700 OHMS TO GREATER THAN 1400 OHMS THE WEEK ENDING (B)(6) 2013.

    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 PATIENT PRESENTED TO THE HOSPITAL BECAUSE OF A PATIENT ALERT AND THE RIGHT VENTRICULAR (RV) LEAD WAS BROKEN. THE RV LEAD WAS CAPPED 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
    82435 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R