BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053322 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04230
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 8, 2013
    Report Date
    April 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WILL BE RETURNED FOR ANALYSIS. UPON RECEIPT, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS LEAD WAS THOROUGHLY INSPECTED AND ANALYZED. TWO SEGMENTS OF LEAD WERE RETURNED. ONE SEGMENT INCLUDED THE PROXIMAL SHOCKING COIL AND THE REMAINDER OF THE LEAD TO THE DISTAL TIP. THE SECOND SEGMENT WAS A MID-BODY SECTION OF LEAD. ON ONE END OF THIS SEGMENT, VISUAL INSPECTION CONFIRMED INSULATION DAMAGE. THE DAMAGE CONSISTED OF A TRILUMEN INSULATION ABRASION THROUGH TO THE LUMEN OF THE RATE/SENSE NEGATIVE (R/S-) COIL. OF NOTE, THE COIL REMAINED ENCASED IN THE INNER INSULATION AND WAS NOT FOUND TO BE EXTERNALIZED FROM THE INSULATION. THE DAMAGE APPEARS CONSISTENT WITH CLAVICULAR/FIRST-RIB ENTRAPMENT.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THE PATIENT REPORTED HAVING EXPERIENCED AN INAPPROPRIATE SHOCK. INTERROGATION OF THIS RIGHT VENTRICULAR LEAD DISPLAYED IMPEDANCE MEASUREMENTS HAD DECREASED TO A LOW OUT OF RANGE MEASUREMENT. THRESHOLD MEASUREMENTS WERE ALSO INCREASED AND NOISE WAS NOTED. A REVISION PROCEDURE WAS PERFORMED. VISUAL OBSERVATION REVEALED THE LEAD CONDUCTOR WAS EXTERNALIZED. INSULATION DAMAGE WAS SUSPECTED. THE LEAD WAS REPLACED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155477 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R T177| 0185