BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3232023 · Received July 17, 2013

    Report

    Report Number
    2124215-2013-11271
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 17, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED A LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENT LESS THAN 200 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332608 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR MISMATCH| 0181| N119| 4473| 4046| 1297| 1688T| H210| H217