BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 4162879 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12564
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 17, 2014
    Report Date
    August 17, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DATA INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. RV DEFIBRILLATION IMPEDANCE WAS STEADY AT APPROXIMATELY 60 OHMS THROUGH 2014-(B)(4) AND ROSE OUT OF RANGE (GREATER THAN 200 OHMS) STARTING BETWEEN 2014-(B)(4).

    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 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. CONCOMITANT MEDICAL PRODUCTS: D354DRG ICD, IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RIGHT VENTRICULAR (RV) LEAD INTEGRITY ALERT TRIGGERED DUE TO HIGH IMPEDANCE WITH A POSSIBLE FRACTURE. THE RV LEAD ALERT BOUNDARY WAS REPROGRAMMED, AND THE LEAD REMAINED IN USE. A FEW DAYS LATER ANOTHER LEAD INTEGRITY ALERT TRIGGERED DUE TO HIGH IMPEDANCE. THE RV LEAD WAS REPLACED BUT REMAINS IN THE PATIENT. HOWEVER, DURING REPLACEMENT THE IMPEDANCE VALUES WERE MEASURED SEVERAL TIMES AND WERE IN NORMAL RANGE. IN ADDITION, CAN AND POCKET MANIPULATION SHOWED NO ABNORMALITIES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640464 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Hospitalization| R 4076 LEAD