BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3760910 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-08901
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    May 18, 2012
    Report Date
    June 24, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE PACING IMPEDANCE MEASUREMENT THAT WAS DETECTED VIA THE PATIENT'S REMOTE HOME MONITORING SYSTEM. THE PHYSICIAN WILL GET A HOLD OF PATIENT TO BE EVALUATED. ADDITIONAL INFORMATION INDICATED THAT THE SOURCE OF HIGH OUT-OF-RANGE PACING IMPEDANCE MEASUREMENT WAS NOT CONCLUSIVELY DETERMINED. ALL OTHER LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS. WITH THIS, THE PATIENT WILL THEN BE MONITORED. THIS SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THIS ICD AND RV LEAD EXHIBITED HIGH, OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE MEASUREMENT GREATER THAN 2000 OHMS. THIS HAS BEEN AN ONGOING ISSUE. FURTHERMORE, THE CAUSE OF HIGH PACING IMPEDANCE WAS STILL NOT CERTAINLY IDENTIFIED. THE PATIENT WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240213 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR 4136| 0185| E110