BEUDAMED
    FDA Adverse Event Death Summary report: N

    PY2 PACING LEAD

    MDR report key: 1616800 · Received February 18, 2010

    Report

    Report Number
    1035166-2010-00013
    Event Type
    Death
    Date Received
    February 18, 2010
    Date of Event
    February 3, 2010
    Report Date
    February 18, 2010
    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

    RETURNED DEVICE ANALYSIS REVEALS THE LEAD IS MEASURING AND FUNCTIONING WITHIN MFG SPECS, THE HELIX CANNOT BE TESTED BECAUSE OF BEING ENCASED IN DRIED BLOOD. THE REASON FOR RETURN CANNOT BE CONFIRMED. CONCERNING A PERFORATION OF THE PT'S HEART WALL IS NOT INHERENT TO THE LEAD DESIGN IF INSTRUCTIONS OF USE ARE BEING FOLLOWED PROPERLY OR IF PT'S HEART TISSUE QUALITY IS ASSESSED. OSCOR INC. IS TRYING TO OBTAIN THE PHYSICIAN'S REPORT FOR ADD'L INFO. SHOULD THE REPORT BE PROVIDED TO OSCOR, THIS EVENT WILL BE REVIEWED FOR ANY NECESSARY UPDATES. THE DEVICE HISTORY RECORDS AND THE COMPLAINT FILES OF THE LEAD MODEL WERE REVIEWED. NO TREND OF THE SAME OR SIMILAR TYPE WAS FOUND OR INDICATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY RECEIVED THE LEAD ON 02/09/2010 FROM THEIR TECHNICAL SERVICE SPECIALIST. ACCORDING TO THE REPORT, DURING THE IMPLANTATION PROCEDURE, THE VENTRICULAR LEAD WENT IN SUCCESSFULLY, BUT WITH THIS ATRIAL LEAD THERE WAS TROUBLE GETTING GOOD NUMBERS. MANY ATTEMPTS WERE MADE BEFORE THE PT'S BLOOD PRESSURE WENT DOWN. THE PHYSICIAN DECIDED AT THAT POINT TO ABORT THE DUAL CHAMBER AND JUST DO A SINGLE CHAMBER SYSTEM. AFTER THIS ATRIAL LEAD WAS TAKEN OUT, IT WAS FOUND THAT ONE OF THE LEADS HAD PERFORATED THE HEART. IT WAS REPORTED THAT IS NOT 100% SURE WHICH LEAD PERFORATED THE HEART, EITHER THIS ATRIAL THAT IS BEING RETURNED OR THE VENTRICULAR LEAD THAT REMAINS IMPLANTED. ADD'L INFO: MR. (B) (6) CALLED ON 02/15/2010 STATING THAT THE PT PASSED AWAY A FEW DAYS AGO. THE EXACT DATE IS NOT KNOWN. MR. (B) (6) STATED THAT THE PT WAS NOT DOING WELL AFTER THE PERFORATION ON (B) (6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PY2 PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. PY2 52 RU 9101109

    Patients

    Seq Age Sex Outcome Treatment
    1 Death REPLY ST, (B) (4)| PY2 52 RU (ELAFIX P2P 752), (B) (4)