BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2050245 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04319
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPROGRAMMED AND A LEAD REVISION WAS PERFORMED. DURING THE REVISION, IT WAS CONFIRMED THAT THE RV LEAD HAD AN INSULATION BREACH BETWEEN THE PROXIMAL DEFIBRILLATION COIL AND THE TERMINAL PIN. THIS LEAD WAS CAPPED AND ABANDONED AND SUCCESSFULLY REPLACED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. 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 DURING A PATIENT FOLLOW UP, IT WAS DISCOVERED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD A SHOCK IMPEDANCE MEASUREMENT BELOW 20 OHMS AND A PACING IMPEDANCE MEASUREMENT BELOW 200 OHMS. IN ADDITION, THE ASSOCIATED DEVICE HAD RECORDED SEVERAL EPISODES DUE TO NOISE OVERSENSING. NO INAPPROPRIATE SHOCKS WERE DELIVERED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A LEAD INSULATION ISSUE IS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 0175| 0148| 1870| T175