BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELAPASS P 758

    MDR report key: 8189652 · Received December 21, 2018

    Report

    Report Number
    1035166-2018-00134
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    November 15, 2016
    Report Date
    December 21, 2018
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    PMA / PMN Number
    K020669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS IN USE FOR TREATMENT AND REMAINS IMPLANTED; THEREFORE, THE CLINICAL OBSERVATION CANNOT BE CONFIRMED. THE LEAD REMAINS ACTIVELY IMPLANTED FOR APPROXIMATELY 9 YEARS, 5 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 DECREASING IMPEDANCE SINCE DEVICE REPLACEMENT IN 2016. THE PACEMAKER WAS REPLACED IN 2016 DUE TO ERI, THE EXACT MONTH AND DAY OF REPLACEMENT ARE NOT AVAILABLE. PATIENT TO RETURN IN SIX (6) WEEKS. THE PATIENT IS PACEMAKER DEPENDENT. THE UNIPOLAR IMPEDANCE IS 270 AND BIPOLAR IMPEDANCE IS 260; AOT IS .75 AND VOT IS .4. ON (B)(6) 2018, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: DECREASING IMPEDANCE FROM AROUND 700 OHMS TO 260 OHMS, SINCE DEVICE REPLACEMENT. DURING PATIENT'S LAST FOLLOW-UP ON (B)(6) 2016, IT WAS REPORTED THE LEAD IMPEDANCE HAD DECREASED. LEAD ABNORMALITY WAS CONFIRMED DURING DEVICE INTERROGATION. THE PATIENT IS BEING MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029542 ELAPASS P 758 PERMANENT PACEMAKER ELECTRODE DTB OSCOR INC. ELAPASS P 758 C3-07591

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention REPLY DR (B)(4)