BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA+ C SERIES SR

    MDR report key: 2420654 · Received January 18, 2012

    Report

    Report Number
    6000095-2012-00002
    Event Type
    Death
    Date Received
    January 18, 2012
    Date of Event
    January 10, 2012
    Manufacturer
    VITATRON MEDICAL B.V.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    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. NO INFORMATION ON LEADS IS KNOWN AT THIS TIME. FOLLOW UP HAS BEEN ATTEMPTED AND ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION HAS COME IN INCLUDING THE MODEL AND SERIAL NUMBER OF THE DEVICE, THE IMPLANT DATE, AND THE CAUSE OF DEATH. THE CAUSE OF DEATH FOR THIS PATIENT HEMODYNAMIC INEFFICIENT CARDIAC CONTRACTION. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE EXACT MODEL OF THE DEVICE IS NOT KNOWN, BUT IT IS A VITATRON DEVICE. NO INFORMATION ON LEADS IS KNOWN AT THIS TIME. FOLLOW UP HAS BEEN ATTEMPTED AND ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE AT THIS TIME. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN CONTACTED A REPRESENTATIVE TO INTERROGATE A "PRESUMED VITATRON PACEMAKER" BECAUSE OF "PRESUMED UNDERSENSING." WHEN THE REPRESENTATIVE GOT TO THE HOSPITAL THEY WERE TOLD THE PATIENT HAD EXPIRED. FURTHER INFORMATION HAS BEEN REQUESTED AND NOT YET MADE AVAILABLE. FURTHER INFORMATION HAS BEEN MADE AVAILABLE ABOUT THE DEVICE AND THE DEATH. THE PATIENT'S CAUSE OF DEATH WAS DUE TO HEMODYNAMIC INEFFICIENT CARDIAC CONTRACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN CONTACTED A REPRESENTATIVE TO INTERROGATE A "PRESUMED VITATRON PACEMAKER" BECAUSE OF "PRESUMED UNDERSENSING." WHEN THE REPRESENTATIVE GOT TO THE HOSPITAL THEY WERE TOLD THE PATIENT HAD EXPIRED. FURTHER INFORMATION HAS BEEN REQUESTED AND NOT YET MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA+ C SERIES SR IMPLANTABLE PULSE GENERATOR DXY VITATRON MEDICAL B.V. C20A4U ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death