BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2040733 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01469
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    November 17, 2010
    Report Date
    January 11, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INCREASE IN PACING IMPEDANCE MEASUREMENTS; HOWEVER, REMAINED WITHIN NORMAL LIMITS. THERE WAS A SLIGHT CHANGE IN SENSING MEASUREMENTS FROM 9 MILLIVOLTS TO 3 MILLIVOLTS. IT WAS NOTED THAT THE PATIENT HAD SINCE DEVELOPED ATRIAL FIBRILLATION (AF). RV THRESHOLD MEASUREMENTS WERE STABLE. TECHNICAL SERVICES (TS) DISCUSSED THE VALUES REMAIN WITHIN NORMAL LIMITS AND WOULD RECOMMEND CONTINUED MONITORING. SUBSEQUENTLY, NOISE WAS SEEN ON THE RATE/SENSE CHANNEL WHICH COULD NOT BE REPRODUCED WITH POCKET MANIPULATION OR ISOMETRICS. THE PATIENT RECEIVED INAPPROPRIATE SHOCKS AS A RESULT OF THE NOISE. THE PATIENT IS PACER DEPENDENT; THEREFORE, THE NOISE ALSO RESULTED IN PACING INHIBITION GREATER THAN 2 SECONDS. TS DISCUSSED PROGRAMMING OPTIONS TO MITIGATE THIS ISSUE. A REVISION PROCEDURE WAS PERFORMED AND THIS LEAD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 69 YR Required Intervention 4470| T165| 0185