BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1870795 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17023
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    January 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PACE/SENSE PORTION OF THE RV LEAD WAS SURGICALLY ABANDONED. THE LEAD IS STILL BEING USED FOR DEFIBRILLATION. ANOTHER RV LEAD THAT WAS PREVIOUSLY SURGICALLY ABANDONED IS NOW BEING USED FOR PACING AND SENSING.

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THAT THE SHOCK PORTION OF THIS RV DEFIBRILLATION LEAD REMAINS IN-SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE LOCAL AREA SALES REPRESENTATIVE INDICATED THAT A CHEST X-RAY WAS TAKEN. THE RESULTS OF THE CHEST X-RAY HAVE NOT YET BEEN COMMUNICATED. THE PATIENT IS NOT PACEMAKER DEPENDENT SO PLANS FOR INTERVENTION ARE NOT URGENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION IN (B)(6) 2012 THAT THIS LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES TO REPORT THAT THE RIGHT VENTRICULAR (RV) SHOCK IMPEDANCE HAD BEGUN TO GRADUALLY INCREASE SINCE (B)(6) 2012.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WERE EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS AT 2500 OHMS. THERE HAD ALSO BEEN AN INCREASE IN PACING THRESHOLDS BY 1.5 V. THE SHOCK IMPEDANCE WAS STABLE AROUND 40 OHMS. SENSING WAS STABLE BETWEEN 10-20 MV. THERE WAS NO EVIDENCE OF NOISE ON THE PRESENTING ELECTROGRAMS OR THE STORED NON-SUSTAINED EPISODES. ISOMETRICS AND POCKET MANIPULATIONS WERE PERFORMED AND WERE NOT ABLE TO PRODUCE ANY NOISE. A CHEST X-RAY PLANNED TO BE PERFORMED TO FURTHER TROUBLESHOOT THE ISSUE. AT THIS TIME THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION IN (B)(6) 2013 FROM THE LOCAL REPRESENTATIVE. THE PHYSICIAN PLANS TO CONTINUE MONITORING THE PERFORMANCE OF THIS LEAD. ACCORDING TO THE LOCAL REPRESENTATIVE, THE PHYSICIAN DID NOT SUSPECT A CONDUCTOR FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention 4457| 4543| 4087| 0175| H210| 1297| 4470