BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 3990120 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08795
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0070-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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: PRODUCT ID 5592-45 CRDM NON-DEFIB LEAD, IMPLANTED: (B)(6) 2002; 4092-52 CRDM NON-DEFIB LEAD, IMPLANTED: (B)(6) 2002; 4193-88 CRDM NON-DEFIB LEAD, IMPLANTED: (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DEVICE REPLACEMENT PROCEDURE, IT WAS NOTED THAT THERE WAS DEGRADATION OF OUTER INSULATION DISTAL TO YOLK. PHYSICIAN SUSPECTS ABRASION DUE TO DEVICE AND LEAD INTERACTION. ELECTRICAL PARAMETERS REMAINED INTACT AND UNAFFECTED. MEASUREMENTS WERE TAKEN AND THE PHYSICIAN DECIDED NOT TO MAKE ANY CHANGES. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462818 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR D224TRK ICD