BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1950613 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23321
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 13, 2010
    Report Date
    March 17, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED SCRATCHES ON THE CASE AND BODY FLUID CONTAMINATION IN THE LEAD BARRELS. A REVIEW OF THE DEVICE MEMORY NOTED NO RESETS OR ERROR CODES. A TWO JOULE INITIAL POLARITY SHOCK WAS ATTEMPTED INTO AN OPEN LOAD. AN OPEN LEAD CONDITION WAS REPORTED. A TWO JOULE REVERSE POLARITY SHOCK WAS ATTEMPTED AND A SHORTED LEAD CONDITION WAS REPORTED. THIS INDICATES THAT THE OUTPUT CIRCUITRY WAS DAMAGED. THE CAUSE OF THE DAMAGED DEFIBRILLATION OUTPUT CIRCUIT IS A DAMAGED LEAD AS NO ARC MARKS WERE FOUND ON THE CASE.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECEIVED AN INAPPROPRIATE SHOCK DUE TO NOISE. THE RV LEAD EXHIBITED SHOCK IMPEDANCE MEASUREMENTS LESS THAN 20 OHMS. IT WAS NOTED THAT THE PATIENT WAS NOT PACER DEPENDENT AS THE PATIENT HAS THEIR OWN UNDERLYING RHYTHM. UPON INTERROGATION, A SHORTED CONDITION MESSAGE WAS RECEIVED. TECHNICAL SERVICES (TS) SUGGESTED TURNING TACHYCARDIA THERAPY OFF TO PREVENT FURTHER INAPPROPRIATE SHOCK. TACHYCARDIA THERAPY WAS TURNED OFF AND THE PATIENT HAS A ZOLL PATCHED ATTACHED. A REVISION PROCEDURE WAS PERFORMED AND THE RV LEAD WAS SURGICALLY ABANDONED DUE TO A FRACTURE. THE DEVICE WAS EXPLANTED DUE TO PATIENT CONDITION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H177

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 0185| H177| 4543| 4087| 4554