BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2171495 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-11664
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 7, 2011
    Report Date
    August 9, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, PRE-DECONTAMINATION INSPECTION NOTED THAT RIGHT VENTRICULAR (RV) POSITIVE SEAL PLUG WAS MISSING AND THERE WAS BODY FLUID CONTAMINATION IN THE LEFT VENTRICULAR (LV) NEGATIVE CONNECTOR BLOCK. POST-DECONTAMINATION MICROSCOPIC VISUAL INSPECTION NOTED A TEAR IN THE LV NEGATIVE SEAL PLUG AND THE RV POSITIVE AND RIGHT ATRIAL (RA) POSITIVE RETAINER RINGS WERE BENT. THIS WOULD INDICATE EXCESSIVE USE OF FORCE TO RETRACT THE SETSCREWS. ALL SETSCREWS MOVED FREELY AND OPERATED NORMALLY. A LEAD WAS INSERTED INTO EACH LEAD BARREL AND EACH SETSCREW TIGHTENED ON THE LEAD PIN WITHOUT DIFFICULTIES. THE DEVICE WAS PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTING. ANALYSIS TESTING COULD NOT CONFIRM THE FIELD REPORT OF A LEAD STUCK IN THE DEVICE HEADER. THE DAMAGE TO THE RA POSITIVE AND RV POSITIVE RETAINER RINGS IS CONSISTENT WITH DAMAGE OCCURRING AS A RESULT OF THE EXPLANT PROCEDURE. ELECTRICALLY, THE DEVICE WAS FOUND TO BE WITHIN NORMAL LIMITS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING ANALYZED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. THIS PRODUCT ISSUE WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. IT WAS NOTED THAT THE ASSOCIATED RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS STUCK IN THE DEVICE HEADER AT THE REPLACEMENT PROCEDURE. THE PIN WAS ABLE TO BE FREED FROM THE DEVICE AFTER A LOT OF MANIPULATION. THE LEAD WAS NOT DAMAGED AND WAS SUCCESSFULLY INTERFACED TO THE REPLACEMENT DEVICE. 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 H175

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR N118| H175| 0184| 4517| 4470