BEUDAMED
    FDA Adverse Event Death Summary report: N

    PY2 PACING LEAD

    MDR report key: 840933 · Received April 19, 2007

    Report

    Report Number
    1035166-2006-00021
    Event Type
    Death
    Date Received
    April 19, 2007
    Date of Event
    August 16, 2006
    Report Date
    March 19, 2007
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RECEIVED WITH A DAMAGED STRETCHED HELIX. THE ELECTRICAL READINGS ARE WITHIN SPEC, NO MFG DEFECTS OR ANY ANOMALIES FOUND. RETURNED DEVICE ANALYSIS REVEALS ALL LEAD FUNCTIONS ARE WITHIN SPECS. THE STRETCHED HELIX MAY HAVE OCCURRED DUE TO EXPLANTATION PROCEDURE. THE EVENT WILL BE REOPENED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THIS LEAD WAS EXPLANTED AS A RESULT OF PT'S DEATH; PT HAD A CARDIAC DEFICIENCY. PRELIMINARY TESTING IN THE FIELD INDICATED THE SYSTEM WAS ACTIVELY DELIVERING SHOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PY2 PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. ELAFIX P2 748 65119

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death| O