BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040636 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00334
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS SYSTEM REMAINS IMPLANTED. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    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 RIGHT VENTRICULAR LEAD AND DEVICE DISPLAYED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. A REVIEW OF TRENDING DATA REVEALED A HIGH OUT OF RANGE SHOCK IMPEDANCE FOR THE PAST ELEVEN MONTHS. THIS INFORMATION WAS PROVIDED TO THE PHYSICIAN AND A LEAD REVISION IS INTENDED. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED FOR THEIR RECOMMENDATIONS AND WAS PROVIDED FURTHER TROUBLESHOOTING RECOMMENDATIONS TO DETERMINE WHETHER THIS IS DEVICE OR LEAD RELATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. A MEMORY DOWNLOAD WAS PROVIDED TO TECHNICAL SERVICES. FURTHER REVIEW OF THE DATA WAS PERFORMED. THE REPORTED OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT IS SUGGESTIVE OF A LEAD INTEGRITY ISSUE OR A CONNECTION ISSUE. A REVIEW OF THE PAST YEAR REVEALED THE ISSUE HAS BEEN CHRONIC WHICH POSSIBLY SUGGESTS A CONNECTION RELATED OBSERVATION. FURTHER RECOMMENDATIONS WERE PROVIDED TO VERIFY A POSSIBLE CONNECTION OR LEAD ISSUE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED: PRIOR TO THE REVISION PROCEDURE, THIS SYSTEM UNDERWENT FLUOROSCOPY. NO ABNORMALITIES WERE NOTED. WHEN THE POCKET WAS OPENED, THE LEADS COULD BE REMOVED FROM THE DEVICE WITHOUT DOING A TUG TEST. WHEN CONNECTED TO THE PACING SYSTEM ANALYZER; (PSA BLACK TO RV PACE/SENSE AND RSA RED TO RV DISTAL LEG) PROXIMAL LEG) PACING WAS NOTED AND NORMAL MEASUREMENTS WERE OBTAINED. THEN THE CONFIGURATION WAS CHANGED (PSA RED TO RV PROXIMAL LEG)PROXIMAL LEG) AND THE LEAD WAS THOROUGHLY CLEANED AND RECONNECTED TO THE CAN. ALL MEASUREMENTS WERE NORMAL. WHEN THIS WAS DONE REPEATEDLY, NORMAL MEASUREMENTS REMAINED NORMAL. DEFIBRILLATION THRESHOLD TESTING WAS NOT PERFORMED. THE POCKET WAS CLOSED AND FURTHER X-RAY REVEALED THE SET SCREW HAD PASSED THE DISTAL BLOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143729 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R T165| F110| 0184| 4469