BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PY PERMANENT PACING LEAD

    MDR report key: 17691041 · Received September 6, 2023

    Report

    Report Number
    1035166-2023-00097
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    August 3, 2023
    Report Date
    September 6, 2023
    Manufacturer
    OSCOR.INC
    Product Code
    DTB
    PMA / PMN Number
    K862330
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LEAD WAS NOT RETURNED FOR ANALYSIS AS LEAD WAS CAPPED AND SURGICALLY ABANDONED DUE TO IT PRESENTING A DEGRADING PERFORMANCE AFTER 25 YEARS IN SERVICE. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL PATIENT EFFECTS WERE REPORTED. THE LEAD WAS IN USE FOR TREATMENT AND THERE WAS NO PRODUCT MALFUNCTION REPORTED. BASED UPON THE IMPLANT DATE OF THIS LEAD (B)(6) 1998, QA IS UNABLE TO REVIEW THE DEVICE HISTORY RECORDS FOR THIS LEAD MODEL AS IT IS BEYOND OSCOR'S RECORD RETENTION PERIOD, HOWEVER, INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT TO PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. THEREFORE, THIS COMPLAINT IS UNCONFIRMED - NO PROBLEM DETECTED. THIS DEVICE IS NO LONGER MANUFACTURED BY MANUFACTURE. NO CORRECTIONS WILL BE TAKEN AT THIS TIME AS NO ALLEGATION WAS MADE AGAINST THE LEAD. 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 · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS CAPPED AND SURGICALLY ABANDONED DUE TO IT PRESENTING A DEGRADING PERFORMANCE AFTER 25 YEARS IN SERVICE. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987999 PY PERMANENT PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB OSCOR.INC PY 44 PSBV

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention