BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2913706 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00420
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 20, 2012
    Report Date
    March 13, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    WITH CURRENT INFORMATION, THE DEVICE AND LEAD REMAIN IN SERVICE, AND THE REPLACEMENT PROCEDURE HAS NOT YET BEEN SCHEDULED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PULSE GENERATOR ASSOCIATED WITH THIS RIGHT VENTRICULAR LEAD HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THEREFORE, A PROCEDURE WILL BE SCHEDULED FOR THE NEAR FUTURE TO REPLACE THE DEVICE, AND THE PHYSICIAN IS CONSIDERING REVISING THE LEAD AT THAT TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT HIGH PACING IMPEDANCES GREATER THAN 2000 OHMS ALONG WITH INCREASED PACING THRESHOLDS WERE DETECTED ON THIS RIGHT VENTRICULAR LEAD AT A ROUTINE FOLLOW UP. IT WAS NOTED THESE MEASUREMENTS HAD BEEN RISING FOR THE PAST 7 MONTHS. ALL OTHER DIAGNOSTICS WERE NOTED TO BE STABLE. THE PHYSICIAN DECIDED TO CONTINUE TO MONITOR THE PATIENT WITH NORMAL FOLLOW UPS AND NO REMEDIAL ACTION TAKEN AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT DURING A NORMAL DEVICE REPLACEMENT PROCEDURE, THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO THE ONGOING LEAD ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21065 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1