BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211302 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08979
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    March 11, 2013
    Report Date
    May 13, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS FOUND DISLODGED DURING A ROUTINE SCHEDULED CLINIC VISIT. LOSS OF CAPTURE WAS NOTED AND A CHANGE IN INTRINSIC R-WAVE MEASUREMENTS FROM 6 MV TO LESS THAN 1 MV. THE PATIENT WAS ASYMPTOMATIC. A REVISION PROCEDURE WAS PERFORMED WERE IT WAS NOTED THE RV DISLODGEMENT WAS DISLODGED DUE TO TWIDDLER'S SYNDROME. FLUOROSCOPIC VIEWS SHOWED THE LEAD SVC COIL PULLED BACK INTO THE DEVICE POCKET. THE LEAD WAS REMOVED AND A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. NO PATIENT INJURY OR COMPLICATIONS WERE NOTED. THE LEAD WAS DISCARDED BY THE HOSPITAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309036 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R 4473| 0295| 4543| 4592| N140