BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040828 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01269
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 5, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SHOCKING PORTION OF THE LEAD REMAINS ACTIVELY IMPLANTED. 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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING AND LOSS OF CAPTURE. THE PATIENT HAD RECEIVED A LEFT VENTRICULAR ASSIST DEVICE AND THIS LEAD WAS DAMAGED DURING THE PROCEDURE. THE PATIENT IS ON THE TRANSPLANT LIST AND THE PHYSICIAN WAS TRYING TO MAKE THE SYSTEM LAST UNTIL A TRANSPLANT COULD TAKE PLACE. THE PACING PORTION OF THIS RV LEAD WAS SURGICALLY ABANDONED AND A NEW PACING LEAD IMPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144209 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| L| R 4592| 4473| N119| 0185