BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1951601 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-24243
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THIS PATIENT'S LATITUDE MONITORING SYSTEM DETECTED A RED ALERT (LOW SHOCK LEAD IMPEDANCE). THE LOCAL REPRESENTATIVE WAS NOTIFIED OF THE ALERT AND THE CLINIC NURSE HAD ALREADY REVIEWED THE DATA FROM THE LATITUDE UPLOAD. SUBSEQUENTLY, THE CLINIC NURSE CONTACTED TECHNICAL SERVICES TO REPORT THAT THERE WAS NO OUT-OF-RANGE (OOR) VALUE IN THE LEAD TREND TABLE. TECHNICAL SERVICES EXPLAINED THAT THE REASON WHY THE OOR VALUE WAS NOT PRESENT IN THE TABLE IS THAT THE OOR CONDITION MAY HAVE OCCURRED WITHIN A 24 HOUR TREND WINDOW WHICH HAD NOT YET ENDED. IT WAS ALSO POSSIBLE THAT 2 SHOCK MEASUREMENTS COULD HAVE OCCURRED WITHIN A 24 HOUR PERIOD. THE FIRST OOR MEASUREMENT MAY HAVE BEEN OVERWRITTEN BY A SECOND NORMAL MEASUREMENT. THE CLINIC NURSE WAS INFORMED THAT THE VALUE COULD BE OBTAINED BY HAVING THE PATIENT PERFORM A PATIENT INITIATED INTERROGATION (PII). HISTORICALLY, THE SHOCK IMPEDANCE MEASUREMENTS HAVE BEEN IN THE MID-50 OHM RANGE. TECHNICAL SERVICES DISCUSSED FURTHER TROUBLESHOOTING OPTIONS AND SUGGESTED ASKING IF THE PATIENT WAS NEAR ANY ELECTROMAGNETIC INTERFERENCE (EMI) SOURCES WHICH MAY HAVE CAUSED AN OOR MEASUREMENT. THE CLINIC NURSE WAS INFORMED THAT A NONINVASIVE PACING STUDY (NIPS) SHOULD BE PERFORMED TO FULLY EVALUATE THE DEVICE'S ABILITY TO DELIVER SHOCK THERAPY EFFECTIVELY. THE CLINIC NURSE WAS PLANNING TO SCHEDULE THE PATIENT FOR FOLLOW-UP. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED EVENT ANALYSIS TO REPORT THAT THIS PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY AND A NONINVASIVE PASING STUDY (NIPS) WAS PERFORMED. A VENTRICULAR ARRHYTHMIA WAS INDUCED AND THE DEVICE APPROPRIATELY SENSED AND DELIVERED SHOCK THERAPY. ADEQUATE DEFIBRILLATION THRESHOLDS WERE OBTAINED AND THE SHOCK IMPEDANCE MEASUREMENTS WERE NORMAL. THE PATIENT CONTINUES TO BE MONITORED ON LATITUDE AND NO INTERVENTION (REPROGRAMMING OR INVASIVE) WAS UNDERTAKEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R E110| T180| 0185| MISMATCH| 0184