BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE LEAD

    MDR report key: 1851550 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-13994
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 15, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPDATED ALERT DATE (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    AT THE MOST RECENT FOLLOW UP WHEN PERFORMING INDUCTION TESTING IN THE DISTAL COIL TO DEVICE CONFIGURATION A 23 JOULE SHOCK WAS EFFECTIVE AND SHOCKING IMPEDANCES APPEARED WITHIN RANGE. AT THIS TIME, THE LEAD AND THE DEVICE REMAIN IMPLANTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE THE SHOCKING CONFIGURATION WAS CHANGED TO A SINGLE COIL SHOCK IMPEDANCE AND THEN TESTED WHICH SHOWED THAT THE SHOCKING IMPEDANCES WERE WITHIN NORMAL RANGE. THE PHYSICIAN BELIEVED THAT THE OUT OF RANGE SHOCKING IMPEDANCES WERE DUE TO A DAMAGED PROXIMAL COIL CONNECTION. INDUCTION TESTING TO VERIFY THE LEAD INTEGRITY AND EFFECTIVENESS OF THE SINGLE COIL CONFIGURATION WILL BE PERFORMED AT A LATER DATE. AT THIS TIME, THE DEVICE AND LEAD REMAINS IMPLANTED. THE PATIENT IS STABLE AND WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED ALERT WAS TRIGGERED DUE TO HIGH OUT OF RANGE SHOCKING IMPEDANCES INVOLVING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). AT THIS TIME NO ACTION HAS BEEN TAKEN TO ADDRESS THIS ISSUE. ANALYSIS OF THE ELECTROCARDIOGRAMS BY TECHNICAL SERVICES NOTED NO NOISE ON THE SHOCK CHANNEL. TECHNICAL SERVICES DISCUSSED A POSSIBLE LEAD ISSUE OR A CONNECTION ISSUE. A FOLLOW UP WAS RECOMMENDED FOR THIS PATIENT IN ORDER TO EVALUATE THE ROOT CAUSE OF THE HIGH SHOCKING IMPEDANCES. NO CHANGE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1