BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 3052622 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04342
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 3, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE DEVICE UPGRADE PROCEDURE DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI), THE ATRIAL AND LEFT VENTRICULAR LEADS WERE REMOVED WITHOUT DIFFICULTY. WHEN THIS RIGHT VENTRICULAR LEAD WAS REMOVED, THE PROXIMAL AND DISTAL COILS WERE REMOVED WITHOUT DIFFICULT HOWEVER THE CATHODE AND ANODE SEPARATED. THE DISTAL PORTION OF THE LEAD REMAINED IN THE DEVICE HEADER. AN ADDITIONAL PACE/SENSE RIGHT VENTRICULAR LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENTLY, THE DEVICE WAS RETURNED WITH THE IS-1 TIP OF THIS LEAD IN THE HEADER. NO LEAD ANALYSIS COULD BE PERFORMED, HOWEVER THE TIP WAS EASILY REMOVED FROM THE DEVICE AND ANALYSIS OF THE DEVICE DID NOT REVEAL ANY SET SCREW ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154418 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0145

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 0145| 1793