BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3052777 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05554
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 3, 2013
    Report Date
    October 2, 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

    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 HOME MONITORING SYSTEM TRANSMITTED A HIGH, OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCE FOR THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS DETECTED. THE PATIENT WAS EVALUATED IN CLINIC, AND THERE WAS A GRADUAL INCREASE IN THE SHOCK LEAD IMPEDANCE MEASUREMENT OVER THE LAST YEAR FROM 65 OHMS TO 124 OHMS. SOME VALUES WERE NOW > 125 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND FURTHER TESTING WAS DONE, AND IT WAS DISCUSSED THERE MAY BE A DISTAL COIL ISSUE. HOWEVER, BEST TEST OF THE SYSTEM WOULD BE 1.1 J AND MAXIMUM ENERGY SYNCHRONIZED, COMMANDED SHOCKS. THE PLAN WAS TO MONITOR. ANOTHER REMOTE TRANSMISSION WAS THEN RECEIVED FOR THE SAME OBSERVATION. IT WAS REPORTED THAT THE PHYSICIAN REQUESTED TO SEE THE PATIENT IN THE CLINIC AGAIN TO DISCUSS OPTIONS WITH THE LEAD. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS THAT THE OBSERVATION OF HIGH, OUT OF RANGE, SHOCK LEAD IMPEDANCES CONTINUES, AND AT THIS TIME THE PLAN IS TO MONITOR. THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE SHOCK LEAD IMPEDANCE MEASURED GREATER THAN 135 ON REMOTE MONITOR TRANSMISSIONS, AS WELL AS, IN THE CLINIC. THEREFORE, SURGICAL INTERVENTION WAS PERFORMED WHERE THE LEAD WAS DISCONNECTED FROM THE DEVICE AND RECONNECTED. THE SHOCK LEAD IMPEDANCE VALUES WERE THEN WITHIN NORMAL RANGE. HOWEVER, THE PHYSICIAN CHOSE TO IMPLANT A NEW RIGHT VENTRICULAR (RV) LEAD, AND THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED. THE ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156483 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R 1853| 4054| E110| 0185