BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1952327 · Received January 7, 2011

    Report

    Report Number
    2124215-2011-00090
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 25, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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

    THE PHYSICIAN ATTEMPTED TO IMPLANT A NEW RIGHT VENTRICULAR DEFIBRILLIATION LEAD. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME, AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD REQUIRED REPOSITIONING ONE DAY POST IMPLANT DUE TO DISLODGEMENT. IT WAS REPORTED THAT THE CAUSE OF THE LEAD DISLODGEMENT WAS THAT THE PATIENT ACTIVELY USED HER ARM AFTER IMPLANT AGAINST THE PHYSICIAN'S ORDERS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED THAT THIS LEAD WAS PULLED BACK, BUT NOT COMPLETELY DISLODGED. THE PATIENT'S THERAPY WAS NOT IMPACTED AND THIS LEAD REMAINS IN SERVICE.

    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 57 YR Required Intervention 4470| 4469| 0185| 0184| E110