BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211090 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08123
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 30, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATION NOTED THE PRESENCE OF DRIED BLOOD/BODY FLUID WAS NOTED IN THE LEAD LUMEN FROM THE TERMINAL PIN TO THE TIP, A PUNCTURE HOLE IN THE LEAD THROUGH TO THE RS AND DISTAL HIGH VOLTAGE LUMENS 207 MILLIMETERS FROM THE TERMINAL PIN AND A CUT IN THE LEAD THROUGH TO THE PROXIMAL HIGH VOLTAGE LUMEN 221 MILLIMETERS FROM THE TERMINAL PIN. RESISTANCE TESTING AND A PRESSURE TEST OF THE INNER INSULATION WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. THE LEAD DID NOT PASS THE GUIDEWIRE TEST DUE TO THE PRESENCE OF BLOOD/BODY FLUID. ANALYSIS CONCLUDED THAT EVEN THOUGH THE LEAD PASSED ELECTRICAL TESTING, A PUNCTURE HOLE THROUGH TO A SENSING CONDUCTOR COIL LED TO THE OBSERVED NOISE.

    Additional Manufacturer Narrative · 1

    THE POCKET WAS REOPENED AND NOISE WAS OBSERVED ON THE RV LEAD, ESPECIALLY WHEN TAPPING ON THE DEVICE. THE DEVICE AND LEAD WERE SUCCESSFULLY EXPLANTED AND REPLACED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING IMPLANT OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND IMPLANTABLE DEFIBRILLATION LEAD, NON-PHYSIOLOGIC SIGNALS WERE OBSERVED ON THE RIGHT ATRIAL (RA), RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) CHANNELS. THE SIGNALS WERE OVERSENSED RESULTING IN PACING INHIBITION FOR THIS PACEMAKER DEPENDENT PATIENT. IT WAS REPORTED THAT THE RA PORT WAS PLUGGED AND PROGRAMMED OFF DUE TO CHRONIC ATRIAL FIBRILLATION (AF). ADDITIONALLY, IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN FELT THE NEEDLE GO THROUGH THE SILICONE OF THE SUTURE SLEEVE, HOWEVER, DIDN¿T FEEL AS THOUGH THE LEAD HAD BEEN PUNCTURED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE ELECTROGRAM (EGM) AND DISCUSSED OVERSENSED COMPLEXES APPEARED TO BE CONSISTENT WITH AIR BUBBLES. TS DISCUSSED IF AIR BUBBLES WERE PRESENT, SHOULD DISSIPATE WITHIN A FEW HOURS. SUBSEQUENTLY, DURING A POST-OPERATIVE FOLLOW UP ONE DAY POST IMPLANT, CONTINUED INTERMITTENT OVERSENSING OF NON-PHYSIOLOGIC COMPLEXES WAS OBSERVED ON THE RV CHANNEL. TS DISCUSSED TROUBLESHOOTING OPTIONS. AN INVASIVE PROCEDURE WAS PERFORMED APPROXIMATELY FIVE DAYS POST IMPLANT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310873 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R 4548| N140| 0296| 4542