BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 3990668 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08532
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 9, 2014
    Report Date
    April 26, 2019
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 429688 LEAD, IMPLANTED (B)(6) 2013; 5076-45 LEAD, IMPLANTED (B)(6) 2005. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL PRODUCT WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND WAS ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. MAX SVC DEFIB IMPEDANCE RISES FROM 69 OHM THE WEEK ENDING (B)(6) 2014 TO GREATER THAN 250 OHM THE WEEK ENDING (B)(6) 2014.

    Additional Manufacturer Narrative · 1

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

    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 OF THE SUPERIOR VENA CAVA DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND OF THE SUPERIOR VENA CAVA DEFIBRILLATION COIL WAS VARIABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD MEASURED HIGH IMPEDANCE ON THE SUPERIOR VENA CAVA (SVC) COIL. THE 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
    467842 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694858

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR D224TRK ICD