BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA CRT-D

    MDR report key: 2231951 · Received September 1, 2011

    Report

    Report Number
    6000094-2011-01829
    Event Type
    Death
    Date Received
    September 1, 2011
    Date of Event
    May 20, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. ALL INFORMATION THAT HAS BEEN MADE AVAILABLE TO MEDTRONIC HAS BEEN REPORTED, IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE FORWARDED.

    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. ALL INFORMATION THAT HAS BEEN MADE AVAILABLE TO MEDTRONIC HAS BEEN REPORTED, IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE FORWARDED. 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. ALL INFORMATION THAT HAS BEEN MADE AVAILABLE TO MEDTRONIC HAS BEEN REPORTED, IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE FORWARDED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO AN EMERGENCY ROOM IN CARDIAC ARREST AND EXPIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT YET MADE AVAILABLE. NO COMPLAINTS OR ALLEGATIONS AGAINST THE DEVICE HAVE BEEN MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D364TRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| H| L| R