BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2122231 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07842
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    January 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. EVALUATION SUMMARY: (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND AN ISSUE WAS FOUND WITH THE CONNECTOR AS THERE WAS INTERMITTENCY BETWEEN THE PIN AND CAP. IT WAS NOTED THAT THE DEFIBRILLATION COIL WAS DISTORTED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO REPLACE THE DEFIBRILLATOR, WHILE RECONNECTING THE RIGHT VENTRICULAR LEAD TO THE NEW DEFIBRILLATOR, HIGH IMPEDANCE WAS FOUND ON THE SVC COIL. THE LEAD WAS REMOVED AND REPLACED. THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) COMPETITOR IMPLANTABLE PACING LEAD