BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2014-16646

    MDR report key: 4150868 · Received October 8, 2014

    Report

    Report Number
    2124215-2014-16646
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 A RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN HIGH OUT-OF-RANGE (OOR) SHOCK IMPEDANCE OF 186 OHMS. A PHYSICIAN DECIDED TO CAP THE RV LEAD AND WILL USE COIL TO CAN. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED WITH A FIELD REPRESENTATIVE THAT THE PATIENT WILL BE BROUGHT FOR DEFIBRILLATION THRESHOLD (DFT) TEST. FURTHER INVESTIGATION WAS PERFORMED, HOWEVER NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS RV LEAD WAS REPORTED TO BE SURGICALLY ABANDONED AND NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633394 NVY GUIDANT PUERTO RICO BV TACHY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R