BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PY PACING LEAD

    MDR report key: 2123466 · Received June 7, 2011

    Report

    Report Number
    1035166-2011-00019
    Event Type
    Malfunction
    Date Received
    June 7, 2011
    Date of Event
    March 24, 2011
    Report Date
    June 2, 2011
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED (CAPPED) WITH NO ADVERSE PATIENT EFFECTS REPORTED, THEREFORE IT WILL NOT BE RETURNED FOR ANALYSIS. AS A RESULT, THE ALLEGATIONS AGAINST THIS LEAD CANNOT BE CONFIRMED. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. LEAD DISLODGEMENT IS A RECOGNIZED CLINICAL EVENT REFERENCED IN THE DEVICE'S LABELING AND/OR REPORTED IN THE MEDICAL LITERATURE. 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 ON (B)(4) 2011, "THE LEADS WERE CAPPED DUE TO LOSS OF VENTRICULAR CAPTURE AND PACING WHICH LED TO 9 SECOND PAUSES. THE CUSTOMERS PACEMAKER WAS ALSO EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ON (B)(4) 2011, THE CUSTOMER REVISED THEIR REPORT TO THE FOLLOWING: "ACCORDING TO THE HOSPITAL RECORDS AND THE SALES REPRESENTATIVE, THE ATRIAL LEAD HAD DISLODGED SOME TIME AGO AND THE PATIENT WAS IN A-FIB AT THAT TIME SO THE DEVICE WAS REPROGRAMMED TO VVI. THE PATIENT WAS ADMITTED ON (B)(6) 2011, WITH THE HOPE TO CONVERT TO SINUS RHYTHM AND REVISE THE ATRIAL LEAD. IT WAS THEN FOUND THAT THE VENTRICULAR LEAD WAS NOT CAPTURING OR PACING WHICH LED TO 9 SECOND PAUSES. BOTH LEADS WERE CAPPED AND THE CUSTOMER'S PACEMAKER WAS EXPLANTED. IT WAS REPORTED THAT THE INTERROGATION THAT WAS PERFORMED FOUND THE RV LEAD HAD MALFUNCTIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED." THE ATRIAL LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 4 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PY PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. PY 48 RSBV 2V11

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR