BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1739262 · Received June 29, 2010

    Report

    Report Number
    2649622-2010-06852
    Event Type
    Death
    Date Received
    June 29, 2010
    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
    MN, US
    Reporter Occupation
    ATTORNEY

    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. THIS EVENT INVOLVES A LEGAL CASE IN PROGRESS OR POTENTIAL LITIGATION. THE PROPRIETARY NATURE OF THE EVENT MAY AFFECT FOLLOW UP EFFORTS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CAUSE OF DEATH WAS REQUESTED BUT NOT RECEIVED. IT IS NOT KNOWN IF THE DEVICE WAS EXPLANTED POST-MORTEM.

    Description of Event or Problem · 1

    A LAWSUIT ALLEGED THE PATIENT 'SUFFERED PHYSICAL AND OTHER INJURY AS A RESULT OF THE RECALLED LEAD' AND WILL SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH' DUE TO THE 'DEFECTIVE' LEAD. EIGHT MONTHS LATER, IT WAS REPORTED THE PT WAS FOUND DEAD AT HOME. DEVICE INTERROGATION SHOWED AN APPARENT 'EPISODE' HAD OCCURRED. A MANUFACTURER'S REPRESENTATIVE STATED 'IT WASN'T NOISE BUT THAT IT WAS A HEART IN TROUBLE.' HE STATED IT LOOKED LIKE THE DEVICE WAS BEHAVING LIKE IT SHOULD, AS PROGRAMMED. THERE WERE A FEW SHORT INTERVALS BUT THERE WAS A WIDE COMPLEX RHYTHM, MUCH LIKE AN AGONAL RHYTHM. NO OVERSENSING OR NOISE WAS SEEN. ONE SHOCK WAS DELIVERED APPROPRIATELY AND SUCCESSFULLY AND THE DEVICE TRIED 3 BEATS OF ATRIAL PACE, BI-VENT PACE, BUT THERE WAS NO CAPTURE, THEN WENT INTO THE PRE-SHOCK, AGONAL-TYPE RHYTHM AGAIN. THERE IS NO ALLEGATION THAT THE DEATH WAS DEVICE-RELATED.

    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 66 YR Death 4194 IMPLANTABLE PACING LEAD| D274TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD