BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2151019 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06061
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 17, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT A REVISION TOOK PLACE. THE PHYSICIAN DISCOVERED THAT THE DISTAL SET SCREW WAS LOOSE. THE DEVICE WAS TAKEN OUT OF THE POCKET AND UPON A TUG TEST THE DISTAL PORTION OF THE LEAD EASILY CAME OUT OF HEADER. THE PHYSICIAN PUT LEAD BACK INTO THE HEADER AND SECURED IT WITH THE SETSCREWS. THE LEAD WAS TESTED WITH 42 OHMS MEASURED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE PRODUCTS REMAIN IN SERVICE. 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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AN HIGH SHOCK IMPEDANCE ON THIS RIGHT VENTRICULAR LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R 4518| 0158| N118| 4087| H175