BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1823833 · Received September 2, 2010

    Report

    Report Number
    2649622-2010-08961
    Event Type
    Death
    Date Received
    September 2, 2010
    Date of Event
    May 13, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S030
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND. (B)(4) DEFIB CONDUCTOR FRACTURED, DEFIB CONDUCTOR DISTORTED, BLOOD/BODY FLUID OUTER TUBING OVERLAY, OUTER TUBING SEPARATION (NON-ELECTRICAL), OUTER INSULATION TORN AND BREACHED CUT, OUTER TUBING OVERLAY BREACHED CUT. FULL LEAD RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), ALL INSULATORS BREACHED CUT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED "I WAS RUSHED TO THE HOSPITAL LAST WEEK AND IN THE AMBULANCE THE EMT SAID THE DEVICE WAS NOT DOING WHAT IT WAS SUPPOSED TO BE DOING. THE (MEDTRONIC) TECH CHECKED THE DEVICE AND SAID EVERYTHING LOOKED OK. I CAN FEEL MY HEART GOING INTO ARRHYTHMIAS AGAIN AND THE DEVICE IS NOT HELPING". ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD RECEIVED APPROPRIATE THERAPY FROM THE DEVICE AND THERE WAS A HIGH IMPEDANCE ON THE RV LEAD. THE PATIENT DIED (B)(6)2009. PER MEDICAL EXAMINER, CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE, NATURAL CAUSES - "ME WAS VERY CLEAR THAT CAUSE OF DEATH WAS NATURAL." NO ALLEGATION BY THE PHYSICIAN THAT DEATH WAS DEVICE OR LEAD RELATED. IT WAS LATER ALLEGED BY FAMILY MEMBER THAT THE PATIENT "DIED AS A RESULT OF SHOCKING FROM A 6948 SPRINT MODEL. (PATIENT) WOULD COMPLAIN ABOUT THE MACHINE TAKING HIM THROUGH SHOCKING ORDEALS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6948 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death