BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910926 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16491
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    September 29, 2012
    Report Date
    January 17, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Removal / Correction Number
    Z-0609-10 TO Z-0610-10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. ONLY THE PROXIMAL PORTION OF THE LEAD WAS RETURNED; IT WAS SEVERED 203MM FROM THE TERMINAL PIN. SET SCREW MARKS WERE NOTED ON THE TERMINAL PINS, BUT NO DISCERNIBLE SET SCREW MARKERS WERE NOTED ON THE IS-1 RING. THERE WAS A SURFACE CUT OF THE TRILUMEN INSULATION AT 132MM FROM THE TERMINAL PIN, AT THE SUTURE SLEEVE TIE DOWN AREA. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. TRILUMEN INSULATION ABRASION WAS OBSERVED 114-155MM FROM THE TERMINAL PIN, AND WAS MOSTLY SUPERFICIAL. HOWEVER, AT 132-135MM FROM THE TERMINAL PIN IT WAS ABRADED TO THE SENSING CONDUCTOR WHERE THE POLYTETRAFLUOROETHYLENE (PTFE) WAS WORN AS WELL. DUE TO THE LOCATION AND TYPE OF DAMAGE IT WAS MOST LIKELY CAUSED BY LEAN-ON-CAN OR LEAD-ON-LEAD CONTACT IN THE POCKET AREA. THE ANALYSIS FINDINGS COULD LEAD TO THE REPORTED FIELD OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT SURGICAL INTERVENTION WAS PERFORMED, THIS DEVICE AND RV LEAD WERE EXPLANTED AND A NEW ICD SYSTEM WAS IMPLANTED. UPON INSPECTION OF THE LEAD IT WAS NOTED THAT THERE WAS DAMAGE TO THE INSULATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD SYSTEM HAVE EXHIBITED NOISE WITH OVERSENSING AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY DELIVERY. NO SHOCKS HAVE BEEN DELIVERED DUE TO THE ISSUE. UPON EVALUATION NOISE WAS ABLE TO BE REPRODUCED WITH ISOMETRICS AND, AT TIMES, LOW OUT-OF-RANGE (OOR) PACING IMPEDANCES OF LESS THAN 200 OHMS WERE MEASURED. THE OVERALL PACING IMPEDANCE HAS TRENDED DOWNWARD FROM 800 OHMS AT IMPLANT APPROXIMATELY THREE YEARS AGO TO 300 OHMS MORE RECENTLY. LEAD FLUOROSCOPY WAS DONE AND NO VISIBLE ANOMALIES WERE IDENTIFIED. THE GENERATOR WAS IMPLANTED SUBPECTORALLY AND IS PART OF THE SUBPECTORAL IMPLANT ADVISORY THAT WAS COMMUNICATED IN DECEMBER 2009. AT THIS TIME, SURGICAL INTERVENTION IS BEING ANTICIPATED IN THE FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18767 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| L| R E102| 0180