BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3152757 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05683
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0068-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. 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. TWO PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6) 2009 AND (B)(6) 2011. WEEKLY PACE LEAD TREND DATA SHOWS A GRADUAL INCREASE FOR MIN AND MAX RIGHT VENTRICULAR (RV) PACE IMPEDANCE OF 1984 TO 2432 OHMS RANGE BETWEEN (B)(6) 2011 AND (B)(6) 2013. PRODUCT: D164AWG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (B)(6) 2007; 5076-52 IMPLANTABLE PACING LEAD (B)(6) 2007. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, AND RETURNED PRODUCT TESTING FOUND THE DEVICE DID PERFORM AS DESCRIBED IN THE FIELD ACTION.  PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE GRADUALLY INCREASED OVER TIME AND IS NOW HIGH. THE LEAD WILL BE REVISED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254468 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693165

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR Hospitalization| R