BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXION PACING LEAD

    MDR report key: 10842615 · Received November 16, 2020

    Report

    Report Number
    1035166-2020-00065
    Event Type
    Malfunction
    Date Received
    November 16, 2020
    Date of Event
    September 17, 2020
    Report Date
    January 28, 2021
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    PMA / PMN Number
    K964107
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. 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 · 0

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP. B4, G3, G6, H2, H10 & H11. CORRECTION: REMOVED H1 MALFUNCTION WHICH WAS SELECTED IN ERROR IN FU 1. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS IN USE FOR TREATMENT. THE DEVICE WAS IN SERVICE FOR APPROXIMATELY 13 YEARS, 7 MONTHS BEFORE BEING EXPLANTED ON (B)(6) 2020. THERE IS NO SPECIFIC PRODUCT PERFORMANCE ISSUE NOTED, THEREFORE, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PERMANENT PACING LEAD FINAL INSPECTION PROCEDURE, FOR THIS DEVICE INDICATES THAT THE LEAD IS CHECKED 100% FOR ELECTRICAL FUNCTION. FINAL QA INSPECTION OF PERMANENT PACING LEADS INCLUDES AN INSERTION/WITHDRAWAL FORCE TEST ON IS-1 CONNECTOR ON THE FIRST AND LAST SERIAL NUMBER OF THE WORK ORDER, AND 100% INSPECTION REGARDING: LENGTH MEASUREMENT OF THE LEAD, DISTAL SPACING MEASUREMENT, PULL TEST ON THE CONNECTOR, ELECTRICAL DC RESISTANCE IS CHECKED RING TO RING, PIN TO TIP AND PIN TO RING (ON PR LEADS, USE HELIX TO CONNECTOR PIN AS CONTACT), MEASUREMENT OF "D" DIMENSION ON IS-1 CONNECTOR AND TUBING INSPECTION IS DONE. FOLLOWING A GENERAL INSPECTION IS DONE OF THE FOLLOWING: VERIFY PROPER APPLICATION OF ADHESIVE; CHECK OUTER HULL TO INNER HULL LASER WELD FOR PROPER PLACEMENT; COIL IS CHECKED FOR KINKS; THE CONNECTOR SLEEVE AND ORINGS ARE EXAMINED FOR NICKS. CUTS, EXCESSIVE FLASH, OR EXCESSIVE ADHESIVE RESIDUES ON ITS SURFACE, ELECTRODES ARE EXAMINED FOR RESIDUE, AND SCRATCHES; ROTATIONAL PIN TO PIN HULL LASER WELD IS CHECKED FOR PROPER WELD, AND HELIX IS CHECKED BY EXTENSION AND RETRACTION. PRIOR TO PACKAGING THE HELIX IS COMPLETELY RETRACTED, AND PROTECTOR TUBING IS ATTACHED. THE PR FLEXION INSTRUCTIONS FOR USE (IFU) INFORMS THE USER OF THESE 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 A 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. IN ADDITION, THE IFU PROVIDES THE USER PRODUCT AWARENESS: 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, FIBROTIC TISSUE PROBLEM, OR A FAILURE OF LEAD BY DAMAGE, FRACTURE, OR BY BREACH OF THEIR INSULATION. THE IFU PRECAUTIONS THE USER: PERFORM PROCEDURE UNDER FLUOROSCOPIC GUIDANCE. 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. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, WHILE IN THE ER TRYING TO INTERROGATE DEVICE PATIENT STATED IT HAD REACHED ERI (ELECTIVE REPLACEMENT INTERVAL) IN 2014. ON 10/20/2020, IT WAS REPORTED THAT THE PATIENT WAS A (B)(6)- YEAR OLD MALE WHO UNDERWENT SURGICAL INTERVENTION TO REPLACE A PULSE GENERATOR, AND IT WAS NECESSARY TO REPLACE LEADS 4017 / BIS10534 AND LEADS 4018 / BIR27805. NO OTHER INFORMATION AVAILABLE. PATIENT WAS HOSPITALIZED, AND LEAD WAS EXPLANTED ON (B)(6) 2020. THERE IS NO SPECIFIC PRODUCT PERFORMANCE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314046 FLEXION PACING LEAD PERMANENT PACEMAKER ELECTRODE, PRODUCT CODE: DTB DTB OSCOR INC. 4018 C2-03409

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention