BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3052745 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04306
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 5, 2013
    Report Date
    May 24, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS NOT BEEN RETURNED AND THEREFORE A TECHNICAL ANALYSIS CANNOT BE CONDUCTED. WITHOUT A RETURNED DEVICE IT IS NOT POSSIBLE TO DEFINITELY CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. 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 DURING THE IMPLANT PROCEDURE, WHEN THIS RIGHT VENTRICULAR LEAD WAS INSERTING THE LEAD INTO A 9F SAFE SHEATH INTRODUCER FOR PLACEMENT, AS THE LEAD WAS PULLED BACK TO REPOSITION, VISUAL OBSERVATION OF THE DISTAL COIL REVEALED THE COILS APPEARED SEPARATED. AS THERE WAS CONCERN THE LEAD MIGHT BE FRACTURED, A DECISION WAS MADE TO REPLACE THIS LEAD. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD WAS DISCARDED AT THE FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156346 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1