BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3051507 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04877
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    July 10, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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. PRODUCT: 7288 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED: (B)(6) 2006, 5076 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2006. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND ANALYSIS REVEALED NO ANOMALIES WERE FOUND. 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. THERE WAS A PATIENT ALERT FOR RV PACE LEAD IMPEDANCE ON (B)(4) 2012 AND (B)(4) 2013. WEEKLY PACE LEAD TREND DATA SHOWS AN INCREASE FOR MAX VENTRICULAR PACE EQUAL TO 784 TO 1216 OHMS PEAK BETWEEN (B)(4) 2012 AND (B)(4) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD INTEGRITY ALERT (LIA) DUE TO INCREASE IN IMPEDANCE FROM NORMAL TO HIGH. IT WAS NOTED THERE WAS INFECTION AND LEAD FRACTURED. THE LEAD WAS EXPLANTED 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
    150040 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R