BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1871203 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17859
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS RV LEAD WAS REMOVED FROM SERVICE, BUT HAS NOT YET BEEN RETURNED TO THE BOSTON SCIENTIFIC CRM POST MARKET QUALITY ASSURANCE LABORATORY FOR ANALYSIS PURPOSES. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE RE-EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) WAS EXPLANTED AS A RESULT OF DECREASED PACE IMPEDANCE TO 297 OHMS AND SOME NOISE. INTERMITTENT LOSS OF CAPTURE WAS SUSPECTED BY THE PHYSICIAN, BUT NEVER CONFIRMED. THERE WERE NO REPORTED ADVERSE PATIENT SYMPTOMS.

    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 60 YR 0185| 5524M| E110| KDR401| 5024M| T125| 4087