BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1905440 · Received November 23, 2010

    Report

    Report Number
    2649622-2010-12121
    Event Type
    Death
    Date Received
    November 23, 2010
    Date of Event
    August 8, 2010
    Report Date
    February 24, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    N

    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 BY THE PATIENT'S SISTER THAT HE HAD BEEN FOUND DEAD IN HIS APARTMENT OVER THE WEEKEND AND QUESTIONED IF AN AUTOPSY SHOULD BE PERFORMED TO DETERMINE IF DEATH "MAY HAVE BEEN DUE TO THE DEVICE." THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP REVEALED PATIENT HAD BEEN EVALUATED IN THE ER ON (B)(6) 2010 AND WAS FOUND TO HAVE HAD VENTRICULAR TACHYCARDIA THAT HAD BEEN ABORTED BY THE DEVICE. THE PATIENT REFUSED HOSPITAL ADMISSION AND WAS DISCHARGED "IN SATISFACTORY CONDITION."

    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 NA Unknown Life Threatening| H| R| D LEAD/STJ IMPLANTABLE PACING LEAD