BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1874982 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18186
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A COMPETITIVE FIELD REPRESENTATIVE THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED PACING IMPEDANCES OF GREATER THAN 2000 OHMS. THE LOCAL BOSTON SCIENTIFIC FR WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING AN ACTION PLAN FOR THE PATIENT. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. THE LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0147

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| MISMATCH| (B)(4)| (B)(4)