BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC III

    MDR report key: 2162741 · Received July 14, 2011

    Report

    Report Number
    6000094-2011-01283
    Event Type
    Death
    Date Received
    July 14, 2011
    Date of Event
    June 24, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P010015/S005
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WITH AN IMPLANTABLE PULSE GENERATOR AND LEAD DIED AFTER EXPLANT OF THE LEAD. THE LEAD WAS SUSPECTED TO HAVE A FRACTURE AS EVIDENCE BY A GAP IN THE CONDUCTOR SEEN ON X-RAY. THE LEAD WAS POSITIONED NEAR THE CLAVICLE. DURING THE EXPLANT PROCEDURE THERE WERE SEVERAL ATTEMPTS TO GET THE WINGS OF THE LEAD DOWN TO GET IT OUT OF THE CORONARY SINUS. THE OUTER BLUE SHEET WAS INTACT BUT BECAUSE OF THE LEAD FRACTURE THERE WAS A LARGE GAP IN THE CONDUCTOR AND THEREFORE NO ESSENTIAL MECHANICAL SUPPORT TO GET THE WINGS DOWN BY MOVING SHEET AND LEAD AGAINST EACH OTHER. AFTER THE LEAD WAS FINALLY REMOVED THE PATIENT'S STATUS BECAME WORSE AND AN EMERGENCY THORACOTOMY WAS NEEDED. THE LEAD HAD PERFORATED THE CORONARY SINUS, THERE WAS UNCONTROLLED BLEEDING AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC III IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. 8042 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death