BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASKU

    MDR report key: 1988723 · Received February 14, 2011

    Report

    Report Number
    2183613-2011-00061
    Event Type
    Death
    Date Received
    February 14, 2011
    Date of Event
    April 26, 2010
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    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 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.

    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) ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. NO ANOMALIES WERE FOUND. THE DEVICE WAS FUNCTIONALLY NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD VALVE SURGERY, AND THE EXTERNAL PULSE GENERATOR (EPG) WAS APPLIED TO THE PATIENT POST-OPERATIVE. THE EPG WAS ON STANDBY, IN DEMAND MODE, AT VVI, RATE OF 45 PACES PER MINUTE, AND THE PATIENT'S OWN HEART RATE WAS 74 BEATS PER MINUTE. IT WAS FURTHER REPORTED THAT THE PATIENT'S POST-OPERATIVE COURSE WAS UNEVENTFUL, UNTIL THE PATIENT WAS FOUND DEAD BY HOSPITAL STAFF FIVE DAYS POST-PROCEDURE. THE EXTERNAL PULSE GENERATOR WAS FOUND TO BE IN AVO MODE, WITH A RATE OF 45 PACES PER MINUTE. RESUSCITATION EFFORTS WERE MADE BUT WERE UNSUCCESSFUL. THE CAUSE OF DEATH HAS BEEN REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD VALVE SURGERY AND THE EXTERNAL PULSE GENERATOR (EPG) WAS APPLIED TO PATIENT POST OPERATIVE. THE EPG WAS ON STANDBY IN DEMAND MODE AT VVI RATE OF 45 PACES PER MINUTE AND THE PATIENT'S OWN HEART RATE WAS 74 BEATS PER MINUTE. IT WAS FURTHER REPORTED THAT THE PATIENT'S POST OPERATIVE COURSE WAS UNEVENTFUL UNTIL THE PATIENT WAS FOUND DEAD BY HOSPITAL STAFF FIVE DAYS POST PROCEDURE AND THE EXTERNAL PULSE GENERATOR WAS FOUND TO BE IN AVO MODE WITH RATE OF 45 PACES PER MINUTE. RESUSCITATION EFFORTS WERE MADE BUT WERE UNSUCCESSFUL. THE CAUSE OF DEATH HAS BEEN REQUESTED BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5388 ASKU

    Patients

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