BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2914299 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00884
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 16, 2012
    Report Date
    October 28, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    --

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID A REPEAT HOME MONITORING CHECK AND THE IMPEDANCE WAS BACK TO THE PREVIOUS TRENDS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME MONITORING SYSTEM DETECTED A HIGH, OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCE FOR THIS RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. THE FIELD REPRESENTATIVE AND PHYSICIAN WERE CONTACTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED WITH THE FIELD REPRESENTATIVE THE SHOCK LEAD IMPEDANCE WAS APPROXIMATELY 50 OHMS JUST OVER A YEAR AGO, AND MORE RECENTLY IT WAS AROUND 110 OHMS. THE OOR MEASUREMENT THAT THE HOME REMOTE MONITORING SYSTEM DETECTED WAS 131 OHMS. IT WAS NOTED BY BOTH THE FIELD REPRESENTATIVE AND PHYSICIAN THAT THE PATIENT HAD A SURGICAL PROCEDURE (NOT DEVICE RELATED) ON THE DAY THE HIGH, OOR, VALUE WAS DETECTED. THE PLAN WAS FOR THE PATIENT TO TRANSMIT ANOTHER READING THROUGH THE HOME MONITORING SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT RECURRENT ALERTS FOR HIGH, OUT OF RANGE, SHOCK LEAD IMPEDANCES WERE RECEIVED. SUBSEQUENTLY, SURGICAL INTERVENTION WAS PERFORMED AND THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS IMPLANTED. THE DEVICE WAS ALSO EXPLANTED AND THE PATIENT RECEIVED A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S HOME MONITORING EQUIPMENT TRANSMITTED THAT ANOTHER HIGH SHOCK LEAD IMPEDANCE HAS BEEN NOTED ON THIS SYSTEM. TS REVIEWED THE INFORMATION WITH THE FIELD REPRESENTATIVE AND THE OUT-OF-RANGE (OOR) IMPEDANCE WAS 131 OHMS. DAILY SHOCK IMPEDANCE WAS TRENDING 111 TO 126 OHMS OVER PAST FEW MONTHS. THE LEAD IS IN THE TRIAD CONFIGURATION. FURTHER INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE THAT THE PATIENT HAS NOT BEEN SCHEDULED FOR IMMEDIATE DEVICE FOLLOW-UP AS THE PATIENT WAS DEALING WITH OTHER MEDICAL CONDITIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED RELATED TO THE DEVICE, AND THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19677 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R E102| T175| 0185