BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZY PERMANENT PACING LEAD

    MDR report key: 9610404 · Received January 21, 2020

    Report

    Report Number
    1035166-2020-00007
    Event Type
    Malfunction
    Date Received
    January 21, 2020
    Date of Event
    January 3, 2020
    Report Date
    January 21, 2020
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    PMA / PMN Number
    K912867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD IS IN USE AND STILL IMPLANTED FOR APPROXIMATELY 24 YEARS, 3 MONTHS, THEREFORE, THE CLINICAL OBSERVATION CANNOT BE CONFIRMED. BASED UPON THE IMPLANT DATE OF THIS LEAD (1995), THE DEVICE HISTORY RECORD FOR THIS LEAD MODEL IS BEYOND OSCOR'S RECORD RETENTION PERIOD. INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT TO PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. A REVIEW OF THE PERMANENT PACING LEAD FINAL INSPECTION PROCEDURE INDICATES THAT THE LEAD IS CHECKED 100% FOR ELECTRICAL FUNCTION. THE PROCEDURE INCLUDES "ACCEPTANCE CRITERIA ALL PRODUCTS MUST MEET PRE-DETERMINED SPECIFICATIONS IN EACH STEP OF THIS PROCEDURE. IF PRODUCT DOES NOT COMPLY WITH SPECIFICATIONS, IT MUST BE REJECTED. AN UNUSUAL OR QUESTIONABLE OR OFTEN REPEATING DEFECT MUST BE REPORTED TO QA MANAGEMENT IMMEDIATELY." ELECTRICAL FUNCTION: ELECTRICAL RESISTANCE HAS TO BE CHECKED WITH A MULTIMETER. RECORD OHMS READINGS ON WORK ORDER. ALL TUBING WILL BE INSPECTED ACCORDING TO THE PROCEDURE # 9B-50-001X-E, "CRITERIA/INSPECTION OF POLYURETHANE AND SILICONE TUBING". THE ELECTRODES SHOULD BE CLEAN AND HAVE NO ADHESIVE OR OTHER RESIDUE. ELECTRODES SHOULD BE SMOOTH AND FREE OF SCRATCHES. PER INSTRUCTIONS FOR USE (IFU) INFORMS THE USER THAT OSCOR'S MEDICAL DEVICES MEET ALL APPLICABLE FEDERAL REGULATIONS GOVERNING STERILIZATION PRIOR TO BEING RELEASED FROM OUR FACILITY. ALL OF OSCOR'S STERILIZED PRODUCTS HAVE CONSISTENTLY PASSED BIOCOMPATIBILITY TESTS PRIOR TO RELEASE IN SHIPMENT. BASED UPON OUR TESTING OF PRODUCTS STERILIZED IN THIS MANNER, OSCOR IS CONFIDENT ITS PRODUCTS ARE SAFE FOR THEIR INTENDED USE. THE LEADS ARE SUPPLIED STERILE. A STERILIZATION METHOD IS INDICATED ON THE PRODUCT LABEL. THE STERILITY IS COMPROMISED WHEN THE PACKAGE IS OPENED OR DAMAGED. OSCOR INC. DOES NOT ASSUME ANY LIABILITY OR RESPONSIBILITY FOR STERILIZATION BY A THIRD PARTY. IN ADDITION, THE IFU LISTS INFECTION AS AN ADVERSE EFFECT: INFECTION, LEAD MAY REQUIRE SURGICAL REMOVAL. THE PACING LEADS ARE IMPLANTED IN THE EXTREMELY HOSTILE ENVIRONMENT OF THE HUMAN BODY. BECAUSE THE LEADS ARE VERY SMALL IN DIAMETER AND MUST BE VERY FLEXIBLE, IT INEVITABLY REDUCES THEIR POTENTIAL PERFORMANCE AND LONGEVITY. LEADS MAY FAIL TO FUNCTION FOR A VARIETY OF CAUSES, INCLUDING MEDICAL COMPLICATIONS, BODY REJECTION PHENOMENON, ALLERGIC REACTION, FIBROTIC TISSUE PROBLEM, OR A FAILURE OF LEAD BY DAMAGE, FRACTURE, OR BY BREACH OF THEIR INSULATION. DESPITE OF ALL DUE CARE IN DESIGN, COMPONENT QUALITY, MANUFACTURE AND TESTING PRIOR TO SALE, LEADS MAY BE DAMAGED BY IMPROPER HANDLING, USE, PLACEMENT OR OTHER INTERVENING FACTS. THIS LEAD IS NO LONGER MANUFACTURED. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS NO ISSUES RELATED TO DESIGN, MANUFACTURING OR LABELING OF THE PRODUCT WERE REVEALED. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMERS MEDICAL RECORDS RECEIVED INFORMATION FROM THE HCP (NON-PHYSICIAN) THAT THIS RIGHT ATRIAL (RA) LEAD HAS BEEN SHOWING INCREASED THRESHOLDS WHICH ARE AFFECTING LONGEVITY AND THE PATIENT NEEDS PACING. HCP PROVIDED NEW ADDRESS AND CORRECT DATE OF BIRTH. THE MODEL, SERIAL NUMBER AND IMPLANT DATE WERE GIVEN TO HCP. LEAD REMAINS IMPLANTED. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74896 ZY PERMANENT PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB OSCOR INC. ZY 52 PJUSBV

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR