BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2853461 · Received November 30, 2012

    Report

    Report Number
    2649622-2012-17481
    Event Type
    Death
    Date Received
    November 30, 2012
    Date of Event
    August 16, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY FURTHER INFORMATION HAS BEEN REQUESTED AND NOT YET MADE AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: FURTHER INFORMATION HAS BEEN REQUESTED AND NOT YET MADE AVAILABLE. EVALUATION SUMMARY: (B)(4) THE LEAD WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. IT WAS FURTHER NOTED THAT BLOOD/BODY FLUID WAS PRESENT ON THE CONDUCTOR (NON-OBSTRUCTING) AND THE INSULATION HAD A COSMETIC DEPRESSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. ACCORDING TO INCOMING INFORMATION, THE EMERGENCY MEDICAL SERVICES PERSONAL STATED THAT THE DEVICE SYSTEM WAS "NOT WORKING." NO FURTHER DETAIL HAS BEEN MADE AVAILABLE AT THIS TIME. NO SPECIFIC COMPLAINTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. ACCORDING TO INCOMING INFORMATION, THE EMERGENCY MEDICAL SERVICES PERSONAL STATED THAT THE DEVICE SYSTEM WAS "NOT WORKING." NO FURTHER DETAIL HAS BEEN MADE AVAILABLE AT THIS TIME. NO SPECIFIC COMPLAINTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Death