BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENSURA DR MRI SURESCAN

    MDR report key: 2231954 · Received September 1, 2011

    Report

    Report Number
    6000094-2011-01830
    Event Type
    Death
    Date Received
    September 1, 2011
    Date of Event
    August 3, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. 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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS, WAS ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE INNER INSULATION WAS BREACHED CUT, THE OUTER INSULATION WAS BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS DECEASED AND DIED AFTER AN ASYSTOLIC EVENT WHICH OCCURED POST COMPUTER TOMOGRAPHY SCAN. RESUSCITATION EFFORTS WERE INITIATED BUT WERE UNSUCCESSFUL. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSURA DR MRI SURESCAN IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. EN1DR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| H| L| R