BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1870072 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-18184
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 20, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    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 COMPETITOR FIELD REPRESENTATIVE (FR) THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD HAS LOSS OF CAPTURE (LOC) AND PACING IMPEDANCES GREATER THAN 2000 OHMS ON THE LEFT VENTRICULAR (LV) CHANNEL. THE LEAD WAS PROGRAMMED LV TIP TO RV RING. THE FR REPROGRAMMED THE LEAD TO LV TIP TO RV COIL WITH GOOD RESULTING NUMBERS. THE FOLLOWING PHYSICIAN DECIDED THAT SINCE REPROGRAMMING RESOLVED THE ISSUE, THAT NO OTHER INTERVENTION WOULD BE PERFORMED. NO ADVERSE PATIENT EFFECTS WERE 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 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR H170| 4538| 0185| MISMATCH| 4087