BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZY PERMANENT PACING LEAD

    MDR report key: 9007205 · Received September 12, 2019

    Report

    Report Number
    1035166-2019-00075
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    August 19, 2019
    Report Date
    September 12, 2019
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    PMA / PMN Number
    K912867
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 1: B1, B2, B4, G4, G7, H2, AND H10 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.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS IN USE FOR TREATMENT. THE LEAD WAS CAPPED (SURGICALLY ABANDONED), THEREFORE, THE REPORTED CLINICAL OBSERVATION COULD NOT BE CONFIRMED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 16 YEARS, 10 MONTHS. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE LEAD PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. A REVIEW OF THE QA 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 PROCEDURE, "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. THE INSTRUCTIONS FOR USE (IFU) FOR PERMANENT IMPLANTABLE PACING LEADS, PROVIDES INFORMATION ON POSSIBLE COMPLICATIONS: WITH THE USE OF ENDOCARDIAL LEADS, COMPLICATIONS MIGHT OCCUR DURING IMPLANTATION, EXPLANTATION OR AT ANY TIME POSTOPERATIVELY AND MAY REQUIRE NON-INVASIVE OR INVASIVE TECHNIQUES FOR MANAGEMENT, AS DETERMINED BY THE CLINICAL JUDGMENT OF THE PHYSICIAN. INTERMITTENT OR CONTINUOUS LOSS OF PACING OR SENSING CAN BE CAUSED BY DISPLACEMENT OF THE ELECTRODE, UNSATISFACTORY ELECTRODE POSITION, BREAKAGE OF THE CONDUCTOR OR ITS INSULATION, AN INCREASE IN THRESHOLDS, OR POOR ELECTRICAL CONNECTION TO THE PULSE GENERATOR. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED. THIS LEAD IS NO LONGER MANUFACTURED BY OSCOR. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE RIGHT ATRIAL (RA) LEAD HAD LOW PACE IMPEDANCE LESS THAN 200 OHMS. NO VISUAL ABNORMALITIES WERE NOTED DURING PROCEDURE, LEAD/HEADER CONNECTIONS WERE FINE; A NEW LEAD WAS IMPLANTED. IT WAS REPORTED THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801613 ZY PERMANENT PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB OSCOR INC. 4037 C2-03954

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention