BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3921623 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-09323
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 19, 2014
    Report Date
    May 27, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED THAT ANOTHER HIGH OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE WAS DETECTED VIA THE PATIENT'S REMOTE MONITORING SYSTEM. FURTHER INVESTIGATION INDICATES THAT THE PATIENT REMOTE MONITORING SYSTEM WAS REPROGRAMMED TO 150 OHMS. THE CAUSE WAS UNDETERMINED. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ADVISED TO BRING PATIENT IN FOR FURTHER EVALUATION. ADDITIONAL INFORMATION OBTAINED FROM FIELD REPRESENTATIVE INDICATING THAT LEAD WAS A SINGLE COIL LEAD AND WAS A NORMAL DEVICE FUNCTION. FURTHER, THE SOURCE WAS UNDETERMINED. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399092 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR E140| 0293