BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1853497 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14805
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 16, 2010
    Report Date
    October 12, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPIRED DUE TO RESPIRATORY ARREST DURING A NON-DEVICE RELATED SPINE SURGERY. THE DEVICE WAS NOT TURNED OFF DURING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHOCK IMPEDANCE MEASUREMENTS LESS THAN 20 OHMS WHICH DID NOT SHOW UP IN THE LATITUDE SYSTEM. TECHNICAL SERVICES (TS) DISCUSSED THAT THE DEVICE IS ON A 21 HOUR CLOCK; THEREFORE, 1 DAY A WEEK THERE ARE 2 MEASUREMENTS THAT ARE TAKEN. TS RECOMMENDED A SYNCHRONIZED MAXIMUM ENERGY SHOCK TO EVALUATE THE SYSTEM FOR A SHORT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PHYSICIAN DID NOT WANT TO DO NON-INVASIVE PROGRAMMED STIMULATION (NIPS). IT WAS NOTED THAT THE PHYSICIAN HAS SEEN THIS BEFORE. WHEN THE PATIENT PERFORMS AN INTERROGATION, THE IMPEDANCE MEASUREMENT WAS 40 OHMS WHICH IS WITHIN RANGE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THIS LEAD WAS SURGICALLY ABANDONED DUE TO THE PATIENT'S DEATH. THERE HAVE BEEN NO PRODUCT PERFORMANCE ALLEGATIONS REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| MISMATCH