BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211314 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07991
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 13, 2013
    Report Date
    January 31, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    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

    ADDITIONAL INFORMATION WAS REQUESTED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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 LEAD CONTINUED TO EXHIBIT A HIGH PACING IMPEDANCE MEASUREMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD HAS EXHIBITED IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS AND HIGH THRESHOLD MEASUREMENTS FOR A YEAR. DURING A RECENT, ROUTINE DEVICE REPLACEMENT PROCEDURE, THE DECISION WAS MADE TO LEAVE THE RV LEAD IMPLANTED. IT WAS SUSPECTED THE RV ISSUES WERE A RESULT OF ABNORMAL CONNECTIVE TISSUE BETWEEN THE TIP OF THE LEAD AND THE HEART TISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED: THE HIGH PACING IMPEDANCE AND THRESHOLD MEASUREMENTS ARE EXPECTED FOR THIS PATIENT. A FOLLOW UP VISIT WAS PERFORMED. ALL MEASUREMENTS WERE STABLE. WHEN THE ALERT WAS RESET AND A FURTHER ALERT WAS TRIGGERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309040 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 T177| 0175