BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2250279 · Received September 15, 2011

    Report

    Report Number
    2649622-2011-13867
    Event Type
    Death
    Date Received
    September 15, 2011
    Date of Event
    July 4, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(6) 2011 OF NOTE, THE REPORTABLE MALFUNCTION AND/OR SERIOUS INJURY IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT SHOULD HAVE BEEN SUBMITTED ON (B)(6) 2011. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(6) 2011 AND REVEALED THE PATIENT DIED. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A THE DEATH. THIS EVENT NO LONGER QUALIFIES FOR BIMONTHLY REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. ATTEMPT(S) FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESS AND CONSIDERED ACCORDINGLY. 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 THAT THE TRANS TELEPHONIC TRANSMISSION APPEARED CONSISTENT WITH NOISE AND THE PACED EVENTS SHOWED POSSIBLE NON CAPTURE. IN ADDITION, IT APPEARED THAT THE ACTIVITY LEVEL WAS NEARLY ZERO. THE PATIENT WAS UNABLE TO BE REACHED AT THE TIME THE CALL CAME TO TECHNICAL SERVICES. INFORMATION IDENTIFIED IN THE MANUFACTURE DATABASE INDICATED THAT THE PATIENT DIED ON THE DAY THESE EPISODES WERE RECORDED. A 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 81 YR Death