BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3051029 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04770
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    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
    VA, US
    Reporter Occupation
    OTHER

    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: 5076 IMPLANTABLE PACING LEAD: (B)(6) 2006. (B)(4).

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH IMPEDANCE IN THE SUPERIOR VENA CAVA (SVC) COIL OF THE RIGHT VENTRICULAR LEAD. IT WAS FURTHER REPORTED THAT THE SVC IMPEDANCE CHANGE WAS DUE TO AN INSULATION BREACH. THE SVC PORTION OF THE LEAD WAS CAPPED AND A PIN PLUG WAS INSERTED IN THE CAN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE SVC COIL CONTINUED TO EXHIBIT HIGH IMPEDANCE AND WAS SUBSEQUENTLY PROGRAMMED OFF. THE DATE THAT THE COIL WAS PROGRAMMED OFF IS UNCLEAR. THE PHYSICIAN PLANS TO PLACE A NEW RIGHT VENTRICULAR (RV) LEAD AS SOME POINT IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153347 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R