BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2162491 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07385
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 19, 2011
    Report Date
    June 29, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    VISUAL INSPECTION REVEALED THAT THE COMPLETE LEAD WAS RETURNED. THE PROXIMAL SHOCKING COIL WAS SEPARATED FROM THE MEDICAL ADHESIVE BONDING AT THE DISTAL END. THERE WERE MULTIPLE CUTS IN THE TRI-LUMAN INSULATION IN THE REGION OF 2832 CENTIMETERS FROM THE IS-1 PIN. THERE WAS DRIED BLOOD NOTED IN THE BASE AROUND THE HELIX AND THE HELIX WAS PHYSICALLY WITHIN SPECIFICATIONS. THE LEAD WAS CONFIRMED TO BE ECLECTICALLY CONTINUOUS. THE CLINICAL OBSERVATION OF DISLODGEMENT WAS UNABLE TO BE REPRODUCED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED DISLODGEMENT. THE PATIENT UNDERWENT A REVISION PROCEDURE. WHILE ATTEMPTING TO REPOSITION THIS LEAD THERE WAS DIFFICULTY EXPERIENCED WHEN TRYING TO ACTIVELY ENGAGE THE HELIX WITH THE PATIENT'S TISSUE. UPON REMOVAL OF THIS LEAD THERE WAS A CONSIDERABLE AMOUNT OF BLOOD/BODY FLUID AT THE TIP OF THE LEAD THAT WAS PREVENTING IT FROM RE-ENGAGING. A NEW LEAD WAS SUCCESSFULLY PLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THIS PRODUCT WAS RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 0184| 4469| E110