BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043176 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-03711
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 19, 2013
    Report Date
    April 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS RIGHT VENTRICULAR (RV) LEAD HAD ABDOMINAL SURGERY. DURING THE POST OPERATIVE CHECK THE LEAD EXHIBITED LOW OUT OF RANGE IMPEDANCE MEASUREMENTS. THE FIELD REPRESENTATIVE MANIPULATED THE POCKET AND DID NOT GET ANY NOISE. ISOMETRICS COULD NOT BE PERFORMED DUE TO THE PATIENT'S RECENT SURGERY. THE ELECTROPHYSIOLOGIST REQUESTED THE DEVICE BE TURNED OFF UNTIL THE RV LEAD HAS BEEN REPLACED. THERE IS CONCERN THAT DURING THE PATIENT'S PROCEDURE, THE SCALPEL OR CAUTERY TOOL MAY HAVE GOTTEN TOO CLOSE TO THE LEAD SYSTEM CAUSING THE RV LEAD TO BE DAMAGED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ADVISED THE OUT OF RANGE MEASUREMENTS WERE MORE LIKELY DUE TO ELECTROMAGNETIC INTERFERENCE (EMI). A MEMORY DOWNLOAD WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) TO BE ANALYZED HOWEVER, THE DISK WAS CORRUPT AND THE DATA UNREADABLE. THE DEVICE WAS TURNED BACK ON AND A COMMANDED SHOCK LEAD INTEGRITY TEST WAS PERFORMED AND CONSISTENTLY GAVE NORMAL IMPEDANCE MEASUREMENTS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146892 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization E162| 0296| 4136