BEUDAMED
    FDA Adverse Event Death Summary report: N

    REFLEX

    MDR report key: 152072 · Received February 6, 1998

    Report

    Report Number
    2017865-1997-01505
    Event Type
    Death
    Date Received
    February 6, 1998
    Date of Event
    January 23, 1995
    Report Date
    September 3, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION EXTRACTED FROM A LEGAL CLAIM NOTES THAT ON JANUARY 23, 1995, THE PATIENT BECAME ILL AND AN AMBULANCE WAS CALLED. AN EMERGENCY MEDICAL RESPONSE PROVIDER DETER- MINED THAT THE PACEMAKER WAS NOT FUNCTIONING. THE PATTIENT WAS TAKEN TO THE HOSPITAL WHERE SHE DIED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX Implant IMPLANTABLE PACEMAKER PULSE GENERATOR DXY TELECTRONICS PACING SYSTEMS INC 8218 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death