BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 5133436 · Received October 7, 2015

    Report

    Report Number
    2649622-2015-10794
    Event Type
    Injury
    Date Received
    October 7, 2015
    Date of Event
    July 23, 2015
    Report Date
    July 23, 2015
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE OVERLAY TUBING OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO MELTING. THE OVERLAY TUBING OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. THIS DEVICE WAS INCLUDED IN A FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT CAME IN FOR A ROUTINE DEVICE GENERATOR CHANGE. HOWEVER, IT WAS DISCOVERED THE PATIENT HAD AN OCCLUDED SUPERIOR VENA CAVA (SVC). THE PATIENT UNDERWENT A LASER LEAD EXTRACTION OF THE EXISTING RIGHT VENTRICULAR (RV) LEAD THE NEXT DAY. DURING THE RV LEAD EXTRACTION, IT WAS NOTED THE INSULATION ON THE LEAD WAS DAMAGED AND THE LEAD WAS EXPERIENCING HIGH CAPTURE THRESHOLDS. THE DEVICE AND LEAD WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663791 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R