BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911409 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16415
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    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 CURRENT 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 DURING A ROUTINE VISIT, THE INITIAL INTERROGATION PRESENTED A LEAD IMPEDANCE ALERT FOR THE SUMMARY PAGE. INSPECTION OF THE RIGHT VENTRICULAR (RV) LEAD DATA REVEALED STABLE SENSING AND PACING IMPEDANCE MEASUREMENTS, WITH AN INITIALLY STABLE SHOCK IMPEDANCE MEASUREMENT OF APPROXIMATELY 40OHMS UNTIL JUNE 2012, WHEN IT BECAME ELEVATED AND VARIABLE. THE SHOCK LEAD CONFIGURATION WAS INITIALLY RV>>CAN+SVC AND ACUTE LEAD TESTING REVEALED A SHOCK IMPEDANCE MEASUREMENT >125OHMS. THE SHOCK LEAD CONFIGURATION WAS REPROGRAMMED TO RV>>CAN AND THE IMPEDANCE VALUE IN THIS CONFIGURATION WAS NORMAL AT 67OHMS. THE SHOCK LEAD CONFIGURATION WAS AGAIN REPROGRAMED TO THE FINAL CONFIGURATION OF RV>>SVC AND AGAIN THE IMPEDANCE VALUE WAS >125OHMS IN THIS CONFIGURATION USING THE SVC COIL. THE PHYSICIAN WAS CONSULTED FOR DATA DISCUSSION, AND IT WAS DECIDED TO PERMANENTLY REPROGRAM THE SHOCK VECTOR TO RV>>SVC. A CONNECTOR ISSUE WITH THE DF-1 SVC PIN IS SUSPECTED. THE PATIENT WAS NOT ORIGINALLY DFT TESTED AT IMPLANT AND THE PHYSICIAN HAS ELECTED TO NOT DFT TEST WITH THE NEW SHOCK VECTOR. THE PATIENT WILL BE FOLLOWED UP IN TWO MONTHS TO CONFIRM LEAD FUNCTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED IN ASSOCIATION WITH THESE OBSERVATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17246 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1