BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3613857 · Received February 8, 2014

    Report

    Report Number
    2649622-2014-00101
    Event Type
    Injury
    Date Received
    February 8, 2014
    Date of Event
    November 1, 2013
    Report Date
    November 7, 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
    IL, 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. CONCOMITANT MEDICAL PRODUCTS: IMPLANTABLE CARDIO-VERTER DEFIBRILLATOR, PRODUCT ID: D314DRG, IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE DUE TO A POSSIBLE LEAD FRACTURE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83431 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Hospitalization| R