BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053153 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04444
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    August 31, 2012
    Report Date
    March 26, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABANDONED LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC THEREFORE, THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED. 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

    TO DATE THE REVISION PROCEDURE HAS NOT YET BEEN PERFORMED. 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

    APPROXIMATELY TWO WEEKS LATER, A REVISION PROCEDURE WAS PERFORMED ON THIS LEAD. DURING THE PROCEDURE HIGH PACING IMPEDANCE GREATER THAN 3,000 OHMS AND NOISE WAS CONFIRMED. THE DECISION WAS MADE TO ABANDONED THE LEAD AND A NEW LEAD WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP THIS RIGHT VENTRICULAR (RV) LEAD REVEALED A RISE IN PACING IMPEDANCES GREATER THAN 3,000 OHMS, IN ADDITION, NOISE WAS OBSERVED WHICH RESULTED IN OVERSENSING OF THE VENTRICULAR. THE LEAD WAS REPROGRAMMED AND A REVISION WAS SCHEDULED FOR THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156544 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L