BEUDAMED
    FDA Adverse Event Death Summary report: N

    RU PERMANENT PACING LEAD

    MDR report key: 7837272 · Received August 31, 2018

    Report

    Report Number
    1035166-2018-00079
    Event Type
    Death
    Date Received
    August 31, 2018
    Date of Event
    June 26, 2018
    Report Date
    August 31, 2018
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    PMA / PMN Number
    K823448
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS IN USE FOR TREATMENT. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 20 YEARS AND CAUSE OF DEATH WAS CARDIAC ARREST. THERE IS NO ALLEGATION THAT THE DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATIONS. BASED UPON THE IMPLANT DATE OF THIS LEAD (1997), 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. THE INSTRUCTIONS FOR USE (IFU) INFORMS THE USER OF THESE POSSIBLE COMPLICATIONS: OSCOR INC.'S IMPLANTED LEADS ARE IMPLANTED IN EXTREMELY HOSTILE ENVIRONMENTS OF THE HUMAN BODY. LEADS ARE NECESSARILY VERY SMALL IN DIAMETER AND MUST BE VERY FLEXIBLE, WHICH UNAVOIDABLY REDUCES THEIR POTENTIAL PERFORMANCE OR LONGEVITY. LEADS FAIL TO FUNCTION FOR VARIETY OF CAUSES, INCLUDING BUT NOT LIMITED TO MEDICAL COMPLICATIONS, BODY REJECTION PHENOMENON, ALLERGIC REACTION, FIBROTIC TISSUE, OR FAILURE OF LEAD BY BREAKAGE, FRACTURE, OR BY BREACH OF THEIR INSULATION COVERING. IN ADDITION DESPITE THE EXERCISES OF ALL DUE CARE IN DESIGN, COMPONENT SELECTION, MANUFACTURE AND TESTING PRIOR TO SALE, LEADS MAY BE DAMAGED BEFORE, DURING, OR AFTER INSERTION BY IMPROPER HANDLING, USE, PLACEMENT OR BY OTHER INTERVENING ACTS. CONSEQUENTLY, NO REPRESENTATION OR WARRANTY IS MADE THAT FAILURE OR SUCCESSION OF FUNCTION OF THE LEAD WILL NOT OCCUR OR THAT THE BODY WILL NOT REACT ADVERSELY TO THE IMPLANTATION OF LEADS OR THAT MEDICAL COMPLICATIONS (INCLUDING PERFORATION OF THE HEART) WILL NOT FOLLOW THE IMPLANTATION OF LEADS OR THAT THE LEAD WILL, IN ALL CASES, RESTORE ADEQUATE CARDIAC FUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO CARDIAC ARREST ON (B)(6) 2018. HOWEVER, NO ALLEGATIONS WERE MADE AGAINST THIS DEVICE. ADDITIONAL INFORMATION WAS REPORTED THE PRODUCT WAS NOT USED FOR ANY PROCEDURE; THE LEAD HAS BEEN IMPLANTED IN THE PATIENT'S BODY SINCE (B)(6) 1997. NO OTHER ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680522 RU PERMANENT PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB OSCOR INC. RU 48 TJSBV

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death