BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3053597 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05180
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE IMPLANT PROCEDURE THE PHYSICIAN NOTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS AND PACING INHIBITION. THE LEAD WAS FOUND TO HAVE DISLODGED. THE RV LEAD WAS REPOSITIONED, HOWEVER DURING THE SECOND REPOSITIONING OF THE LEAD PHYSICIAN NOTED THE LEAD HAD DISLODGED AGAIN DURING SEWING OF THE SUTURE. THE LEAD WAS ATTEMPTED TO BE REPOSITIONED A THIRD TIME AND THE LEAD DISLODGED AGAIN CAUSING THE RIGHT ATRIAL (RA) LEAD TO DISLODGE AS WELL. THE ATRIAL LEAD WAS SUCCESSFULLY REMOVED; HOWEVER THE PHYSICIAN EXPERIENCED REMOVAL DIFFICULTY OF THE RV LEAD DUE TO A STUCK HELIX. AFTER MULTIPLE ATTEMPTS THE RV LEAD WAS ALSO SUCCESSFULLY REMOVED AND A NEW RA AND RV LEAD WERE IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEADS WERE DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155865 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1