BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PY2 PACING LEAD

    MDR report key: 1961356 · Received December 17, 2010

    Report

    Report Number
    1035166-2010-00071
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 15, 2010
    Report Date
    December 17, 2010
    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 EXPLANTED AND A NEW LEAD IMPLANTED WITH NO ADVERSE PT EFFECTS REPORTED. THE MANUFACTURER ATTEMPTED TO OBTAIN THE LEAD BY SENDING LETTERS TO THE PHYSICIAN (ON (B)(4) 2010) BUT WAS INFORMED BY THE PHYSICIAN'S OFFICE (ON (B)(4) 2010) THAT THE DEVICE WOULD NOT BE RETURNED, IT WAS NO LONGER IN THEIR FACILITY. AS A RESULT, THE REPORTED ALLEGATION CANNOT BE CONFIRMED. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFO BECOMES AVAILABLE. THRESHOLD ELEVATION 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 THIS VENTRICULAR LEAD WAS REMOVED BECAUSE, IT WAS REPORTED THERE WERE HIGH THRESHOLD READINGS; NO CAPTURE. A NEW LEAD WAS IMPLANTED AND NO ADVERSE PT EFFECTS WERE REPORTED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 3 YEARS.

    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 710453

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR