BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3961771 · Received July 28, 2014

    Report

    Report Number
    2124215-2014-12532
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    May 15, 2014
    Report Date
    July 7, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (B)(4). THE PATIENT WILL CONTINUE TO BE MONITORED. RECORDS INDICATE THIS SYSTEM REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT OF RANGE SHOCK LEAD IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS WHICH WAS DETECTED VIA THE PATIENT REMOTE MONITORING SYSTEM. IT WAS NOTED THAT SHOCK IMPEDANCE WAS GRADUALLY INCREASING OVER TIME. SUBSEQUENTLY, THE PATIENT WAS BROUGHT IN FOR FURTHER EVALUATION AND TWO CONSECUTIVE IMPEDANCE READINGS OF 116 OHMS WERE OBSERVED. FURTHERMORE, NOISE WAS ELICITED WITH ISOMETRICS ON SHOCK CHANNEL BUT NOT ON RV PACE/SENSE CHANNEL. NO FURTHER INTERVENTIONS WERE PERFORMED AND THE PATIENT WOULD CONTINUE TO BE MONITORED. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT ANOTHER ALERT WAS DETECTED FOR HIGH, OUT OF RANGE SHOCKING LEAD IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS. THIS HAS BEEN AN ONGOING ISSUE AND THE PATIENT WILL CONTINUE TO BE MONITORED. NO TESTING WAS MADE AND THE CAUSE WAS NOT DETERMINED. THE SYSTEM STILL REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439669 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR E140| 0292