BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3052787 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05006
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 3, 2013
    Report Date
    April 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A WEAKENED HEADER BOND. VISUAL INSPECTION NOTED THAT THE DEVICE HEADER WAS SLIGHTLY LOOSE BUT STILL ATTACHED TO THE DEVICE CASE. X-RAY EXAMINATION WAS PERFORMED. THE HEADER WIRES WERE VERIFIED TO BE INTACT. IMPROVEMENTS HAVE BEEN MADE TO THE MANUFACTURING PROCESS IN ORDER TO STRENGTHEN THE BOND BETWEEN THE HEADER AND THE DEVICE CASE. ANALYSIS ALSO REVEALED THE RV LEAD HAD NOT BEEN FULLY INSERTED BY EVIDENCE OF LEAD SEAL RING MARKS IN THE RV HEADER PORT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT INCREASED LEFT VENTRICULAR (LV) AND RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE MEASUREMENTS WERE NOTED VIA REMOTE MONITORING NINE YEARS AFTER THE LEADS WERE INITIALLY IMPLANTED. INITIALLY A LEAD FRACTURE WAS SUSPECTED ON THE RV LEAD AS MEASUREMENTS OF GREATER THAN 2000 OHMS WERE OBSERVED AND A REVISION PROCEDURE WAS SCHEDULED. NO DOCUMENTED LOSS OF CAPTURE (LOC) WAS FOUND, HOWEVER IT WAS REPORTED THAT THE PATIENT MAY HAVE HAD A SYNCOPAL EPISODE, THE PATIENT IS PACEMAKER DEPENDANT. THE LV LEAD PACE IMPEDANCE MEASUREMENTS ALSO EXCEEDED 2000 OHMS A FEW DAYS LATER. UPON OPENING THE POCKET, THE LEADS WERE TESTED VIA THE PACING SYSTEM ANALYZER (PSA) AND ALL LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE LEADS WERE RECONNECTED TO THE DEVICE AND A LEAD EXTRACTION WAS SCHEDULED FOR THE NEXT DAY AT A NEW FACILITY. THE NEXT DAY A REVISION PROCEDURE WAS PERFORMED, HOWEVER A HEADER OR SETSCREW ISSUE WAS SUSPECTED UPON SEEING THE NORMAL LEAD MEASUREMENTS DURING IMPLANT TESTING AND WITH THE NEW DEVICE. AFTER THE REPLACEMENT OF THIS FOUR YEAR OLD DEVICE IMPLANTED SUBCUTANEOUSLY, THE LEADS APPEARED TO BE WORKING NORMALLY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155066 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R 4537| N119| H170| 0157| 5076