BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 3951083 · Received July 22, 2014

    Report

    Report Number
    2649622-2014-07660
    Event Type
    Death
    Date Received
    July 22, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS NOT ACTIVE AT THE TIME OF THE INFECTION EVENT. THE LEAD HAD BEEN CAPPED DUE TO A MALFUNCTION WHICH WAS REPORTED VIA REMEDIAL ACTION EXEMPTION ON (B)(6) 2013. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 THAT THE PATIENT DIED DURING AN EXTRACTION PROCEDURE WHICH WAS ONLY PERFORMED DUE TO A POCKET INFECTION. THIS LEAD WAS INCLUDED IN A FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED THAT THIS DEVICE PERFORMED 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 A POCKET INFECTION OCCURRED AND THE PATIENT WAS REFERRED FOR SYSTEM EXTRACTION. DURING THE EXTRACTION OF THE PRIOR CAPPED RIGHT VENTRICULAR (RV) LEAD THE SUPERIOR VENA CAVA (SVC) WAS TORN AND THE PATIENT EXPERIENCED A HEMOTHORAX. EMERGENCY SURGERY WAS REQUIRED TO ATTEMPT TO REPAIR THE SVC TEAR. THE SURGICAL TEAM WAS UNABLE TO GET PATIENT ON CARDIAC BYPASS AND REPAIR THE TEAR. THE PATIENT EXPIRED ON THE TABLE IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428339 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Death 6947M62 LEAD, D334VRM ICD