BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 3022725 · Received March 27, 2013

    Report

    Report Number
    2182208-2013-00492
    Event Type
    Death
    Date Received
    March 27, 2013
    Date of Event
    August 1, 2012
    Report Date
    March 1, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. IT IS NOT KNOWN WHETHER THE PATIENT'S DEVICE IS AN IMPLANTABLE PULSE GENERATOR (IPG) OR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD); THEREFORE, IT WILL BE REPRESENTED AS: MDT-ICD. THERE IS NO SERIAL NUMBER. FOLLOW-UP IS IN PROGRESS. THE DECISION TO REPORT WAS DETERMINED BASED ON INFORMATION THAT WAS AVAILABLE AT THE TIME OF DECISION. SHOULD ADDITIONAL INFORMATION BECOME KNOWN THROUGH FOLLOW-UP, IT WILL BE ADDED TO THE EVENT AND PROCESSED ACCORDINGLY. THE PATIENT AND DEVICE SYSTEM INFORMATION, AND THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE MANUFACTURER'S REPRESENTATIVE WAS EATING DINNER WHEN ANOTHER PERSON HEARD THE REPRESENTATIVE WAS OF THIS MANUFACTURER. THE PERSON STATED "A FAMILY MEMBER PASSED AWAY", AND FELT A PROBLEM WITH THIS MANUFACTURER'S "PACEMAKER OR DEFIBRILLATOR MAY HAVE CONTRIBUTED TO THE DEATH". NO FURTHER INFORMATION WAS PROVIDED BY THE PERSON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125129 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 Death