BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELAPASS PJ 752

    MDR report key: 8202694 · Received December 28, 2018

    Report

    Report Number
    1035166-2018-00138
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    August 23, 2018
    Report Date
    December 28, 2018
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    PMA / PMN Number
    K020669
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD IS IN USE FOR TREATMENT AND IS IMPLANTED, THEREFORE, THE CLINICAL OBSERVATION CANNOT BE CONFIRMED. THE LEAD REMAINS ACTIVELY IMPLANTED FOR APPROXIMATELY 9 YEARS, 11 MONTHS. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. COMPLAINT REVIEW IDENTIFIED NO ADDITIONAL REPORTS. PER THE QA PETITE AND PETITE J IN-PROCESS AND FINAL INSPECTION PROCEDURE, THE PROCEDURE INDICATES THAT THE LEAD IS CHECKED 100% FOR ELECTRICAL FUNCTION. THE PROCEDURE 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, PULL TEST ON THE CONNECTOR, ELECTRICAL DC RESISTANCE IS CHECKED RING TO RING, PIN TO TIP AND PIN TO RING. TUBING INSPECTION IS INSPECTED ACCORDING TO CRITERIA/INSPECTION OF POLYURETHANE AND SILICONE TUBING. 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, VERIFY PRESENCE OF WELD SPOTS ON THE CONNECTOR HULL, WELD SHOULD BE SMOOTH AND SHINY, AND VERIFY THAT THERE IS NO HOLE IN LASER WELD IMPRESSION. PER ELAPASS P/PJ PHYSICIANS MANUAL, IT INFORMS THE USER OF 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. AFTER IMPLANTATION THE PATIENT SHOULD BE MONITORED FOR SEVERAL DAYS FOR ELECTRODE DISPLACEMENT, AND THE LEAD SHOULD BE REPOSITIONED IF NECESSARY. LATERAL LEAD TIP PLACEMENT IN THE ATRIUM OR PERFORATION OF LATERAL ATRIAL WALL MAY CAUSE PHRENIC NERVE STIMULATION. PERFORATION OF THE VENTRICLE WALL MAY CAUSE DIAPHRAGMATIC MUSCLE STIMULATION AND ALSO CARDIAC TAMPONADE. IT IS DIFFICULT TO EXPLANT A PASSIVE LEAD DUE TO ITS INGROWN DISTAL END. IT IS RECOMMENDED TO CAP THE PROXIMAL PORTION OFF WHENEVER THE LEAD WILL BE IN THE HEART. PRECAUTIONS: THE USE OF THE SUBCLAVIAN VEIN PUNCTURE TECHNIQUE FOR LEAD INTRODUCTION MAY BE ASSOCIATED WITH CONDUCTOR FRACTURES, IRRESPECTIVE OF LEAD MANUFACTURER. IF THE PHYSICIAN ELECTS TO USE THE SUBCLAVIAN VEIN PUNCTURE, A MORE LATERAL PUNCTURE SITE SHOULD BE CONSIDERED TO AVOID THE SUBCLAVIAN MUSCLE AND COSTOCLAVICULAR LIGAMENT, OR AT LEAST ITS DENSEST PART. THE PROCEDURE IS SUGGESTED TO BE DONE UNDER FLUOROSCOPIC GUIDANCE. AFTER PLACEMENT, THE LEAD SHOULD BE CHECKED BY MULTIVIEW CINERADIOGRAPHY DURING MOVEMENTS OF THE IPSILATERAL UPPER EXTREMITY TO ENSURE THE LEAD(S) HAVE NOT BEEN ENTRAPPED. THE POSTEROANTERIOR CHEST X-RAY CAN ALSO BE USED TO CONFIRM THAT LEAD(S) HAVE NOT BEEN ENTRAPPED. 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. THE ELAPASS-P AND ELAPASS-PJ MODELS ARE PASSIVE FIXATION LEADS SPECIFICALLY INDICATED FOR CASES WITH CONGENITAL OR ACQUIRED HEART DISEASE AND WHERE PASSIVE FIXATION LEAD PROVIDES SATISFACTORY POSITIONING STABILITY IN THE VENTRICLE OR THE ATRIAL APPENDAGE. 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. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE.

    Description of Event or Problem · 1

    ON DECEMBER 3, 2018 THE CUSTOMER REPORTED ATRIAL LEAD REMAINS IMPLANTED; IMPEDANCE IS DECREASING, AND HAS NOISE. BIPOLAR IMPEDANCE 621. AOT .75 AND VOT .75. MONITORING PATIENT EVERY FOUR (4) MONTHS. THE CUSTOMER REPORTED THIS ADDITIONAL INFORMATION ON DECEMBER 11, 2018. THE PHYSICIAN REPORTED DECREASING IMPEDANCE AND NOISE RELATIVE TO THE SUBJECT LEAD. DURING LAST FOLLOW-UP ON (B)(6) 2018, LEAD ABNORMALITY WAS CONFIRMED DURING DEVICE INTERROGATION. NO IMPACT TO PATIENT, NO ADVERSE PATIENT EFFECTS AND NO EXTENDED HOSPITALIZATION WERE REPORTED. FOLLOW-UP MEASUREMENTS DURING THE DEVICE INTERROGATION CONFIRMED THE LEAD ABNORMALITY. THE PATIENT WILL CONTINUED TO BE MONITORED EVERY FOUR (4) MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041424 ELAPASS PJ 752 PERMANENT PACEMAKER ELECTRODE DTB OSCOR INC. ELAPASS PJ 752 OR-02552

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR