BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3990147 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08794
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH 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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. CONCOMITANT PRODUCTS: D334TRG ICD, IMPLANTED: (B)(6) 2012; 4524-53 LEAD IMPLANTED: (B)(6) 1998; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED EARLY BATTERY DEPLETION. THE RIGHT ATRIAL (RA) LEAD TRIGGERED A WARNING DUE TO LOW PACING IMPEDANCE AND ALSO EXHIBITED OVERSENSING. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. DURING THE EXPLANT OF THE DEVICE, THE PHYSICIAN NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD APPARENT BREAKS IN THE INSULATION DISTAL TO TRIFURCATION. THE RV LEAD WAS ALSO 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
    465026 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R 419488 LEAD