BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 3210468 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06726
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 23, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT THIS DEVICE WILL UNDERGO DETAILED LABORATORY TESTING IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED TOOL MARKS ON THE HEADER. THE HEADER WAS ALSO FOUND TO LOOSE AND THE MEDICAL ADHESIVE THAT COVERS THE LEADS TERMINAL BLOCKS WAS MISSING. IN ADDITION THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD SEAL PLUGS WERE ALSO MISSING FROM THE DEVICE. ALL OTHER SEAL PLUGS WERE CONFIRMED TO BE INTACT. A LEAD WAS INSERTED INTO EACH LEAD BARREL AND EACH SET SCREW HELD THE LEAD IN PLACE. THE TWO RETAINER RINGS ARE DAMAGED. HOWEVER, ALL SET SCREWS OPERATE NORMALLY. THE DEVICE WAS THEN EXPOSED TO THERAPY VERIFICATION TESTING AND THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. A REVIEW OF THE DEVICE MEMORY NOTED NO RESETS OR FAULT CODES. THE DEVICE RECORDED 11 ECC MEMORY CORRECTIONS WITH THE LAST ONE OCCURRING IN (B)(6) 2008. THIS INDICATES NORMAL FUNCTION. ANALYSIS CONCLUDED THAT THIS OCCURRED DURING IMPLANT AND WAS INDUCED DAMAGE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A RECENT DEVICE REPLACEMENT PROCEDURE, THE PHYSICIAN NOTED THAT HE WAS UNABLE TO REMOVE THE RIGHT VENTRICULAR (RV) LEAD FROM HE DEVICE HEADER (THE SERIAL NUMBER OF THE LEAD IS UNKNOWN). THE DEVICE WAS CHANGED OUT FOR A COMPETITOR DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309756 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H235

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R