BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053266 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05471
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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. THE LEAD WAS RETURNED SEVERED IN TWO SEGMENTS 13.2 CM FROM THE TERMINAL PIN. THERE WERE SETSCREW MARKS NOTED ON ALL TERMINAL CONNECTORS, AND NO IRREGULARITIES WERE NOTED. VISUAL INSPECTION OF THE TERMINAL CONNECTOR REGION OF THE LEAD FOUND NO ANOMALIES. THERE WAS CALCIFICATION NOTED ON THE PROXIMAL SHOCKING COIL AND OVER MOST OF THE DISTAL POROUS MESH SCREEN TIP. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE INTEGRITY, HOWEVER, ONE PORTION WAS EVALUATED BY X-RAY AS THE EXTRACTING STYLET WAS PRESENT. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS, AND THERE WAS NO EVIDENCE OF A CONDUCTOR FRACTURE. DEPENDING ON HOW MUCH CALCIFICATION WAS PRESENT ON THE TIP OF THE LEAD BEFORE EXTRACTION, THE IMPEDANCE MEASUREMENTS COULD HAVE BEEN IMPACTED. RELATED TO THE OBSERVATION THAT THERE APPEARED TO BE A CRIMP IN THE LEAD, THIS WAS NOT VERIFIED AS VISUAL INSPECTION REVEALED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    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 DURING A GENERATOR CHANGE-OUT FOR NORMAL BATTERY DEPLETION, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE, PACING IMPEDANCES GREATER THAN 2000 OHMS, AND SENSING ISSUES WHEN CONNECTED TO THE NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE LEAD WAS THEN TESTED WITH THE PACING SYSTEM ANALYZER (PSA) AND IMPEDANCES WERE 1800-2000 OHMS. THE NEW DEVICE WAS AGAIN RECONNECTED TO THIS RV LEAD AND IMPEDANCES REMAINED GREATER THAN 2000 OHMS. DATA FROM THE PREVIOUS GENERATOR WAS REVIEWED, AND FOR THE YEAR PRIOR TO THE CHANGE-OUT, THE RV PACING IMPEDANCES WERE STABLE AT 1700 TO 1800 OHMS, CAPTURE THRESHOLDS WERE 2.7 TO 3.0 VOLTS AT 1.0MS, AND NO ISSUES WERE NOTED WITH THE LEAD'S PERFORMANCE. FLUOROSCOPY EVALUATION WAS DONE ON THE LEAD AND IT APPEARED THERE WAS A CRIMP IN THE LEAD NEAR THE VEIN ENTRY POINT. THE LEAD WAS SUCCESSFULLY EXTRACTED AND REPLACED. THE NEW RV LEAD WAS CONNECTED TO THE SAME NEW GENERATOR AND MEASUREMENTS WERE NORMAL AND DEFIBRILLATION THRESHOLD (DFT) TESTING WAS SUCCESSFUL. THERE WERE NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS NOT PACEMAKER DEPENDENT AND RECEIVED NO INAPPROPRIATE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156970 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0174

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR E161| 0174| T175| 0180