BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2153584 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06734
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT, THE IMPLANTING PHYSICIAN DID SURGICALLY ABANDON THIS LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR )RV) LEAD DID EXHIBIT GREATER THAN 125 OHMS SHOCK IMPEDANCE DURING THE NORMAL DEVICE CHANGEOUT PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THE ASSOCIATED MEDICAL DEVICE HAD NO ALLEGATION.

    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 75 YR 0185| 7120| T165| 4470| 4554| N119