BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2151370 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06062
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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.

    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.

    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 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 4518| N118| H175| 4087| 0158