BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3152747 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05687
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 29, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. (CONT): 5568 IMPLANTABLE PACING LEAD 2007-(B)(6); 4194 IMPLANTABLE PACING LEAD 2007-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT (LIA) TRIGGERED. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD FAILED. CLARIFYING INFORMATION WAS ATTEMPTED TO BE OBTAINED, HOWEVER, IT WAS NOT AVAILABLE. THE RV 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
    255460 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R D314TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR