BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASKU

    MDR report key: 2003391 · Received March 1, 2011

    Report

    Report Number
    6000094-2011-00349
    Event Type
    Death
    Date Received
    March 1, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. CORRECTION TO NUMBER OF PATIENTS INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DIED AS A RESULT OF A CARDIAC ARREST. FURTHER REPORTED THAT THE LEAD IMPLANTED WITHIN THIS PATIENT GOT DISCONNECTED DURING UNCONTROLLED MOVEMENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH THE PHYSICIAN LATER REVEALED THAT THE DEVICE SYSTEM HAD NOT CONTRIBUTED TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DIED AS A RESULT OF A CARDIAC ARREST. FURTHER REPORTED THAT THE LEAD IMPLANTED WITHIN THIS PATIENT GOT DISCONNECTED DURING UNCONTROLLED MOVEMENT. THE CAUSE OF DEATH AND ANY ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. ICD/MEDT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death