BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211047 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08336
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    February 3, 2009
    Report Date
    June 14, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE COMPLETE LEAD WAS RETURNED SEVERED IN TWO SEGMENTS APPROXIMATELY 13.5 CM FROM THE LEAD¿S TERMINAL PIN. VISUAL INSPECTION NOTED THAT THERE WERE SETSCREW MARKS ON ALL TERMINAL CONNECTORS. THERE WAS CALCIFICATION COVERING MOST OF THE DISTAL SHOCKING COIL AND OVER THE ELECTRODE END OF THE LEAD. IN ADDITION, THERE WAS DAMAGE NOTED ON THE DISTAL SEGMENT OF THE LEAD, MOST LIKELY INDUCED DURING THE EXPLANT PROCEDURE. AN X-RAY WAS PERFORMED AND THERE WERE NO SIGNS OF A LEAD FRACTURE. RESISTANCE TESTING WAS PERFORMED ON THE PROXIMAL LEAD SEGMENT TO ASSESS THE ELECTRICAL PERFORMANCE AND THE MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. NO TESTING WAS ABLE TO BE PERFORMED ON THE DISTAL LEAD SEGMENT DUE TO THE EXCESSIVE DAMAGE SUBJECTED TO THIS LEAD PORTION DURING THE EXPLANT PROCEDURE. LABORATORY TESTING WAS UNABLE TO CONFIRM THAT THE LEAD HAD FRACTURED; HOWEVER, THE CALCIFICATION THAT WAS COVERING THE DISTAL SHOCKING COIL AND ELECTRODE END MAY HAVE CONTRIBUTED TO THE INCREASE IN SHOCK IMPEDANCE MEASUREMENTS NOTED WHILE THE LEAD WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

    ONCE ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ---

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SINCE 2009, THE SHOCK IMPEDANCE MEASUREMENTS ON THIS RIGHT VENTRICULAR (RV) LEAD HAVE BEEN INCREASING; HOWEVER, THE VALUES NEVER WENT ABOVE 125 OHMS. ALL OTHER LEAD MEASUREMENTS HAD REMAINED STABLE; HOWEVER, SOME NOISE WAS OBSERVED ON THE SHOCK CHANNEL. NO ADVERSE PATIENT EFFECTS WERE REPORTED. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED IN 2010 AND THE SHOCK IMPEDANCE MEASUREMENTS WERE STILL IN NORMAL RANGE. THE PATIENT CONTINUED TO BE CLOSELY MONITORED AND THE LEAD REMAINED IMPLANTED AND IN SERVICE. THREE YEARS LATER, THE SHOCK IMPEDANCE MEASUREMENTS ON THIS RV LEAD HAD INCREASED TO 138 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND THE TS CONSULTANT DISCUSSED THAT TESTING THE SYSTEM THROUGH COMMANDED SHOCKS WOULD PROVIDE MORE INSIGHT ON THE INTEGRITY OF THE RV LEAD AND SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT REVISION WAS PERFORMED DUE TO THE FRACTURE OF THIS RV LEAD. THE ENTIRE SYSTEM WAS EXPLANTED. THE LEAD AND ASSOCIATED DEVICE WERE NOT REPLACED AS THEY WERE UNCOMFORTABLE FOR THE PATIENT. THE PATIENT HAS A LIFE VEST UNTIL A DECISION IS REACHED ON WHETHER OR NOT TO IMPLANT A NEW SYSTEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE FIELD REPRESENTATIVE DID NOT KNOW IF THE LEAD AND DEVICE WERE GOING TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311484 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 272 MO T135| T175| MISMATCH| 0180