BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1675560 · Received May 6, 2010

    Report

    Report Number
    2649622-2010-01920
    Event Type
    Death
    Date Received
    May 6, 2010
    Date of Event
    March 19, 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
    MI, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD INAPPROPRIATE THERAPY DUE TO OVERSENSING AND LEAD FRACTURE. IT WAS ALSO REPORTED THE LEAD HAD IMPEDANCES OUT OF RANGE. ON (B)(6) 2010, THE PATIENT HAD REPLACEMENT SURGERY OF THE DEVICE AND THE PACING LEAD. LATER REVIEW OF MANUFACTURING DATABASE THE PATIENT HAD DIED THREE DAYS AFTER THIS PROCEDURE. FOLLOW UP WITH THE PHYSICIAN REPORTED THE CAUSE OF DEATH WAS CARDIAC AND WAS RELATED TO A MALFUNCTION OF THE GENERATOR OR LEAD SYSTEM. HE REPORTED " 'NOISE' DUE TO A FIDELIS FRACTURE RESULTED IN MULTIPLE INAPPROPRIATE ICD SHOCKS; SHE HAD UNDERLYING AF AND MUST HAVE EMBOLIZED DURING 1 OF THESE SHOCKS - SHE DIED OF COMPLICATIONS OF MULTIPLE EMBOLI."

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD INAPPROPRIATE THERAPY DUE TO OVERSENSING AND LEAD FRACTURE. IT WAS ALSO REPORTED THE LEAD HAD IMPEDANCES OUT OF RANGE. ON (B)(6)-2010, THE PATIENT HAD REPLACEMENT SURGERY OF THE DEVICE AND THE PACING LEAD. LATER REVIEW OF MANUFACTURING DATABASE, THE PATIENT HAD DIED THREE DAYS AFTER THIS PROCEDURE. FOLLOW UP WITH THE PHYSICIAN REPORTED THE CAUSE OF DEATH WAS CARDIAC AND WAS RELATED TO A MALFUNCTION OF THE GENERATOR OR LEAD SYSTEM. HE REPORTED " 'NOISE' DUE TO A FIDELIS FRACTURE RESULTED IN MULTIPLE INAPPROPRIATE ICD SHOCKS; SHE HAD UNDERLYING AF AND MUST HAVE EMBOLIZED DURING 1 OF THESE SHOCKS - SHE DIED OF COMPLICATIONS OF MULTIPLE EMBOLI." FOLLOW UP REVEALED THE DEVICE WAS REPLACED DUE TO BEING CLOSE TO ERI. THE PACING PORTION OF THE LEAD WAS CAPPED AND REPLACED DUE TO THE FRACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD INAPPROPRIATE THERAPY DUE TO OVERSENSING AND A LEAD FRACTURE. IT WAS ALSO REPORTED THE LEAD HAD IMPEDANCES OUT OF RANGE. ON (B) (6) 2010, THE PATIENT HAD REPLACEMENT SURGERY OF THE DEVICE AND THE PACING LEAD. LATER REVIEW OF MANUFACTURING DATABASE, THE PATIENT DIED THREE DAYS AFTER THIS PROCEDURE. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH IS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    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 87 YR Death