BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2052178 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04662
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE DEVICE WAS REMOVED, REPLACED, AND RETURNED FOR ANALYSIS. AS THE ABANDONED LEAD WAS NOT RETURNED FOR ANALYSIS, THE CLINICAL OBSERVATIONS OF THE LEAD COULD NOT BE CONFIRMED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR UNDERWENT A PULMONARY ABLATION DUE TO ATRIAL FIBRILLATION. DURING THE PROCEDURE EXTERNAL DEFIBRILLATION WAS REQUIRED. THE PATCHES OF THE EXTERNAL DEFIBRILLATOR HAD BEEN ATTCHED ON THE LEFT AND RIGHT SIDES OF THE PATIENT'S CHEST. AFTER THE ABLATION PROCEDURE THE DEVICE WAS INTERROGATED AND HIGHER THAN BEFORE STIMULATIONS THRESHOLDS AND PACING IMPEDANCES ON THE RIGHT VENTRICULAR DEFBIRLLATION LEAD AND LEFT VENTRICULAR LEAD WERE FOUND. IN ADDITION, A LOW SHOCK IMPEDANCE MEASUREMENT WAS NOTED DUE TO AN ALERT MESSAGE OF LOW SHOCK IMPEDANCE LESS THAN 20 OHMS NOTIFICATION. THIS WAS LIKELY A RESULT OF THE COMMANDED 31J SHOCK REQUIRED DURING THE ABLATION PROCEDURE. THIS WAS A COMMANDED SHOCK FOR CARDIOVERSION TO TERMINATE ATRIAL FIBRILLATION. THE DEVICE WAS INTERROGATED; THE ATRIAL LEAD REVEALED NORMAL VALUES AND PARAMETERS. THE RIGHT VENTRICULAR SENSING WAS NORMAL, HOWEVER, HIGH PACING IMPEDANCE AND HIGH THRESHOLDS WERE NOTED. THE SHOCK IMPEDANCE WAS NORMAL DURING INTERROGATION. THE LEFT VEDNTRICULAR IMPEDANCE WAS GREATER THAN 2,000 OHMS, AND THRESHOLDS WERE HIGH. ALL OTHER MEASUREMENTS WERE NORMAL. A REVISION PROCEDURE WAS PERFORMED; UPON REMOVAL OF THE DEVICE, A BLACK MARK WAS NOTED ON THE DEVICE. THE RIGHT VENTRICULAR LEAD HAD BEEN LYING ON THE BLACK MARK OF THE DEVICE AND THE LEAD INSULATION WAS DAMAGED. A SHORTED LEAD CONDITION WAS SUSPECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R