BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNET, TEST, PACEMAKER

    MDR report key: 4970302 · Received August 5, 2015

    Report

    Report Number
    2182208-2015-02448
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 13, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT PATIENT ENCOUNTERED A HEMATOMA AND SANDBAG PLACED OVER RIGHT FEMORAL ARTERY PUNCTURE PERFORMED, NO TREATMENT WAS NECESSARY. PI ASSESSED EVENT AS RESEARCH PROCEDURE RELATED AND NOT SERIOUS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF THE LEFT VENTRICULAR (LV) LEAD, AFTER ALL THE LEADS WERE PLACED, PHYSICIAN SLIT THE LV SHEATH AND THE LV LEAD COMPLETELY DISLODGED FROM THE POSTERIOR-LATERAL VEIN. THE LV LEAD WAS REMOVED AND EXCHANGED FOR ANOTHER LEAD. PHYSICIAN BELIEVED THE EVENT WAS RELATED TO THE SHEATH AND SLITTER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS A PARTICIPANT IN THE SENSOR OPTIMIZATION OF CARDIAC RESYNCHRONIZATION THERAPY RESPONSE CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516507 MAGNET, TEST, PACEMAKER DTG MEDTRONIC, INC. MDT-SLITTER

    Patients

    Seq Age Sex Outcome Treatment
    1