BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1771562 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-13260
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 7, 2010
    Report Date
    May 18, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THESE MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Additional Manufacturer Narrative · 1

    MOST RECENTLY, INFORMATION WAS RECEIVED TO BOSTON SCIENTIFIC THAT THE LOCAL AREA SALES REPRESENTATIVE DID A DEVICE FOLLOW UP, PERFORMING A COMMANDED 31 JOULES SHOCK WITH AN SHOCK LEAD IMPEDANCE (CLI) TESTIING MEASUREMENT RESULT OF 47 OHMS. THE FOLLOWING PHYSICIAN ELECTED TO MONITOR ONLY AT THIS TIME. A MAX ENERGY SHOCK WAS GOING TO BE DONE IN THE NEAR FUTURE TO TEST THE SYSTEM. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT RECOMMENDED REPLACING THE LEAD AT THIS TIME, INSTEAD OF PERFORMING A MAXIMUM ENERGY SHOCK WOULD RESULT IN A SHORTED CONDITION OF THE DEVICE AND RECOMMENDED DEVICE REPLACEMENT. IT WAS NOT KNOWN AT THE TIME OF THIS REPORT WHETHER THE LEAD HAD BEEN REPLACED OF IF A MAXIMUM ENERGY SHOCK HAD BEEN TESTED. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THIS ISSUE. THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTS THAT THIS RIGHT VENTRICULAR (RV) LEAD CONTINUES TO DISPLAY LOW SHOCK IMPEDANCE MEASUREMENTS. ISOMETRICS WERE PERFORMED AND THERE WAS NO NOISE OBSERVED. THE PHYSICIAN IS ELECTING TO CONTINUE TO MONITOR AT THIS TIME SINCE THIS IS A KNOWN ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT UPON INTERROGATION, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IN ASSOCIATION WITH THIS TRANSVENOUS DEFIBRILLATION LEAD EXHIBITED <20 OHMS SHOCK IMPEDANCE. SHOCK IMPEDANCE HAD HISTORICALLY BEEN NOTED IN THE 50'S BUT HAS INTERMITTENTLY EXHIBITED <20 OHMS. EVEN WITH ISOMETRICS, THE VALUES WERE NOTED AS WITHIN NORMAL LIMITS. A POSSIBLE DEFIBRILLATION LEAD INSULATION ISSUE WAS SUSPECTED. THE FOLLOWING PHYSICIAN HAD NOT DONE ISOMETRICS, CHEST X-RAY, OR MAXIMUM ENERGY SHOCK TESTING TO DATE. IT WAS NOT KNOWN IF THE PATIENT HAD TWIDDLER'S SYNDROME OR NOT EITHER. THERE WAS NO REPORT OF ADVERSE PATIENT SYMPTOM ASSOCIATED WITH THESE CLINICAL OBSERVATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention (B)(4)| MISMATCH| (B)(4)| (B)(4)