BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXION PACING LEAD

    MDR report key: 7914340 · Received September 27, 2018

    Report

    Report Number
    1035166-2018-00026
    Event Type
    Death
    Date Received
    September 27, 2018
    Date of Event
    February 23, 2018
    Report Date
    September 27, 2018
    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 · 1

    BASED ON OUR FINDINGS, IT WAS DISCOVERED THE INITIAL MDR 1035166-2018-00026 (B)(4) REPORT HAD FAILED SUBMISSION. WE HAVE CORRECTED THE REPORTED FAILURE IN THIS INITIAL MDR REPORT. CONCOMITANT MEDICAL PRODUCTS: THE FOLLOWING ASSETS WERE PART OF THE SYSTEM EXTRACTION ON (B)(6) 2018. RV LEAD: 0184/316495, RELIANCE G ACTIVE FIX DUAL COIL 59CM CRT-D: N119/987477, COGINS HE IS-1/DF-1/IS-1 LV LEAD: 4554/175077, ACUITY STEERABLE LVA DUAL ELECTRODE IS-1 PASSIVE 80CM 23. THE DEVICE HAD BEEN IN USE FOR TREATMENT AND IN SERVICE FOR APPROXIMATELY 16 YEARS, 10 MONTHS. THIS LEAD IS NO LONGER MANUFACTURED BY OSCOR. THE DEVICE HISTORY RECORDS (DHR) FOR THIS LEAD DEVICE ARE NOT AVAILABLE FOR REVIEW AS IT IS BEYOND OSCOR'S RECORD RETENTION PROCEDURE, HOWEVER, INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. THE MANUFACTURING 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), "D" DIMENSION ON IS-1 CONNECTOR IS MEASURED AND TUBING INSPECTION IS DONE. 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 O-RINGS 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. THE 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 FOLLOWING PRECAUTIONS: CLINICAL EVIDENCE SUGGESTS THAT CERTAIN UPPER EXTREMITY ACTIVITIES ARE CONTRAINDICATED FOR PERSONS WITH PERMANENT PACEMAKERS BECAUSE THEY REQUIRE MOVEMENTS THAT CAN CAUSE DAMAGE TO THE LEADS AND POSSIBLE FAILURE OF THE LEADS. ACTIVE PEOPLE, PARTICULARLY THOSE WHO PERFORM REPETITIVE UPPER EXTREMITY EXERCISE AT WORK OR PLAY, SHOULD BE CAUTIONED THAT THEY COULD SUBJECT LEADS TO DAMAGING STRESS. BE SURE TO LEAVE SUFFICIENT SLACK IN THE LEAD TO COMPENSATE FOR BODY MOVEMENTS. ELECTRICAL ISSUES ARE RECOGNIZED CLINICAL EVENTS REFERENCED IN THE INSTRUCTIONS FOR USE (IFU). AS OF THIS DATE, THE DEVICE IN QUESTION HAS NOT BEEN RETURNED FOR EVALUATION AND AS SUCH, ANY ALLEGATIONS AGAINST THIS LEAD CANNOT BE CONFIRMED INCLUDING ALLEGATIONS OF ELECTRICAL ISSUES. BASED ON THIS INFORMATION A CAPA IS NOT REQUIRED. OSCOR WILL CONTINUE TO MONITOR THIS DEVICE FOR COMPLAINT TRENDS AND RISK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FIELD CLINICAL REPRESENTATIVE CONTACTED THE REPORTER'S TECHNICAL SERVICES. INFORMATION WAS RECEIVED THAT THE PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY FOR SYSTEM EXTRACTION FOR UNKNOWN REASONS. DURING THE SYSTEM EXTRACTION PROCEDURE THE INFERIOR VENA CAVA (IVC) WAS TORN. THE CHEST WAS OPENED AND EMERGENCY INVASIVE MEASURES WERE UNDERTAKEN. DESPITE THESE MEASURES, THE PATIENT DID NOT RECOVER AND DIED. THE INITIAL REPORTER RECEIVED INFORMATION FROM THE FIELD CLINICAL REPRESENTATIVE THAT BOTH THE CHRONIC IMPLANTABLE RIGHT VENTRICULAR (RV) DEFIBRILLATION AND CHRONIC IMPLANTABLE RIGHT ATRIAL (RA) LEADS WERE NOT PERFORMING AS NEEDED. THE FIELD CLINICAL REPRESENTATIVE WAS UNSURE IF THE LEADS WERE EXHIBITING SENSING OR PACING ISSUES. THE CHRONIC DEVICE AND LEADS WERE EXPLANTED AND SHIPPED BACK TO INITIAL REPORTER. NO FURTHER INFORMATION WAS PROVIDED OR MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756833 FLEXION PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB OSCOR INC. 4015

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death