BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PY2 PERMANENT PACING LEAD

    MDR report key: 10710578 · Received October 21, 2020

    Report

    Report Number
    1035166-2020-00059
    Event Type
    Injury
    Date Received
    October 21, 2020
    Date of Event
    September 19, 2020
    Report Date
    November 12, 2020
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    PMA / PMN Number
    K041809
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D8 WAS SELECTED FOR INITIAL SUBMISSION. THIS SHOULD HAVE BEEN BLANK. THE DEVICE WAS IN SERVICE FOR APPROXIMATELY 11YEARS, 5 MONTHS BEFORE BEING EXPLANTED ON (B)(6) 2020. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS BEFORE SHIPPING TO THE CUSTOMER. THE LEAD WAS EXPLANTED DUE TO AN INFECTION (PATIENT CONDITION), WHICH DOES NOT REFLECT THE PERFORMANCE OF THE PRODUCT. NO SUBSEQUENT DEVICE OR CLINICAL ADVERSE EVENTS HAVE BEEN REPORTED. NO ALLEGATION OUR DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATIONS OR CAUSED OR CONTRIBUTED TO THE INFECTION. PROOF OF STERILIZATION IS ON FILE. INFECTION 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 DEVICE MODEL WERE REVIEWED. NO TREND OF THE SAME OR SIMILAR TYPE WAS FOUND OR INDICATED. BASED ON INVESTIGATION A CAPA IS NOT REQUIRED. THIS LEAD IS NO LONGER MANUFACTURED BY OSCOR. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED IN RELATION TO THESE LEADS AND THE ASSOCIATED PACEMAKER (REPLY DR, SN: (B)(4)) IMPLANTED ON (B)(6) 2018: ON (B)(6) 2020, DR. (B)(6) REQUESTED A CHECK FOR THE ASSOCIATED PACEMAKER AT (B)(6) MEMORIAL IN (B)(6). EROSION OF THE SUBJECT DEVICES WAS REPORTED AND THEY WERE SUBSEQUENTLY EXPLANTED THE FOLLOWING DAY. THEY WILL NOT BE MADE AVAILABLE FOR RETURN ANALYSIS. AFFECTED LOTS: ATRIAL OSCOR ELA FIX P2P744 SERIAL (B)(4), (B)(6) 2009. VENTRICULAR OSCOR ELA FIX P2P758, SERIAL (B)(4), (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178520 PY2 PERMANENT PACING LEAD PERMANENT PACEMAKER ELECTRODE, PRODUCT CODE: DTB DTB OSCOR INC. ELAFIX P2P 744 C2-10537

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention