BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2162619 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07564
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 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

    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 PATIENT, IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS IN FOR A PROCEDURE TO REVISE ANOTHER MANUFACTURER'S LEFT VENTRICULAR (LV) LEAD. DURING THE DISSECTION PROCESS, BOTH THE ATRIAL AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEADS WERE DAMAGED DUE TO SIGNIFICANT MANIPULATION TO FREE THE LEADS FROM BUILT UP SCAR TISSUE. THE ATRIAL LEAD WAS UNABLE TO PACE AND WAS CONSIDERED FRACTURED. THE RV DEFIBRILLATION LEAD'S PACING IMPEDANCES AND THRESHOLD MEASUREMENTS INCREASED AND SHOCK IMPEDANCES WERE HIGH AND OUT OF RANGE. THE LV PORT ON THE DEVICE WAS PLUGGED AND TACHY THERAPY WAS TURNED OFF. THE PATIENT'S POCKET WAS CLOSED AND A LEAD EXTRACTION AND EPICARDIAL LV LEAD PLACEMENT PROCEDURE WAS SCHEDULED. THE PATIENT IS NOT PACEMAKER DEPENDENT AND NO ADVERSE ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED BEYOND THE EXTENDED HOSPITAL STAY UNTIL A NEW EPICARDIAL LV LEAD AND RV DEFIBRILLATION LEAD COULD BE IMPLANTED. TWO DAYS LATER ANOTHER MANUFACTURER'S EPICARDIAL LV LEAD AND RV DEFIBRILLATION LEAD WERE IMPLANTED. WHEN THE LEADS WERE CONNECTED TO THE CRT-D AND DEFIBRILLATION THRESHOLD TESTING WAS PERFORMED, MEASUREMENTS WERE HIGH. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE CRT-D WITH ANOTHER MANUFACTURER'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H210

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization 4470| H210| 4548| MISMATCH| 1861| 0157| 4136| 4542