BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140192 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16835
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    July 9, 2014
    Report Date
    September 10, 2014
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. 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 DURING A NON-BOSTON SCIENTIFIC DEVICE UPGRADE, THIS CHRONIC RIGHT VENTRICULAR LEAD DISPLAYED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. IN A DIFFERENT VECTOR, NORMAL SHOCK IMPEDANCE MEASUREMENTS WERE OBTAINED. A FURTHER INTERROGATION REVEALED SHOCK IMPEDANCE MEASUREMENTS WITHIN ACCEPTABLE RANGE. AS THE DATA REVEALED THE MEASUREMENTS HAVE REMAINED STABLE, A DECISION WAS MADE TO FURTHER MONITOR THIS LEAD. IT WAS THOUGHT THE ISSUE MAY BE DUE TO A DRY POCKET AND WITH THE PRODUCT COATING, A HIGHTER THAN EXPECTED HIGH VOLTAGE IMPEDANCE FROM RV TO CAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619502 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS GUIDANT PUERTO RICO BV 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 4087| 4517| 0184| H175