BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1990641 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-03017
    Event Type
    Death
    Date Received
    February 15, 2011
    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
    AU
    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 (OVERSENSING, POSSIBLE LEAD FRACTURE AND INAPPROPRIATE THERAPY) IS NORMALLY SUBMITTED VIA A SUMMARY MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE 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 DEATH, THIS EVENT NO LONGER QUALIFIES FOR SUMMARY REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO LEAD OVERSENSING AND POSSIBLE LEAD FRACTURE. THE LEAD WAS SCHEDULED FOR REPLACEMENT BUT THE PATIENT'S EJECTION FRACTION HAD IMPROVED TO GREATER THAN 50%. DUE TO THE IMPROVED EJECTION FRACTION, THE PATIENT'S THERAPY WAS DEACTIVATED AND PLANS WERE MADE TO EXPLANT THE SYSTEM AND NOT REPLACE IT. IT WAS FURTHER REPORTED THAT THE PATIENT DIED WHILE SHOVELING SNOW. THE CAUSE OF DEATH HAS BEEN REQUESTED BUT 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 46 YR Death| H| L| R