BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4132268 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15419
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    April 1, 2014
    Report Date
    July 18, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED DECREASING IMPEDANCE MEASUREMENTS DOWN TO 200 OHMS WITH A MODERATE INCREASE IN THRESHOLD MEASUREMENTS. THIS PATIENT IS PACEMAKER DEPENDENT. NO CHANGES TO THE SYSTEM HAVE BEEN SCHEDULED OR PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613159 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 P108| 4592| MISMATCH| 0293