BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 6888084 · Received September 22, 2017

    Report

    Report Number
    2182208-2017-01459
    Event Type
    Death
    Date Received
    September 22, 2017
    Date of Event
    April 26, 2005
    Report Date
    January 23, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. POSSIBLE MODEL COULD INCLUDE KSP401. THE DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT; AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS 77 YEARS OLD. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: INTRATHORACIC IMPEDANCE MONITORING IN PATIENTS WITH HEART FAILURE. CIRCULATION 2005;112:841-848.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE PULSE GENERATORS (IPGS) AND IMPLANTABLE PACING LEADS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTS THAT THERE WERE PATIENT DEATHS. THE AUTHOR ADDITIONALLY REPORTED DURING HOSPITALIZATIONS, PULMONARY CAPILLARY WEDGE PRESSURE AND FLUID STATUS WERE MONITORED. PATIENTS WERE HOSPITALIZED FOR FLUID OVERLOAD. PERFORMANCE OF THE IPG DETECTION ALGORITHM WAS EVALUATED. IT WAS NOTED THAT FALSE POSITIVES WERE OBSERVED AND DEFINED AS ANY OCCASION WHEN THE FLUID INDEX EXCEEDED THE THRESHOLD. THE STATUS OF THE DEVICES IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ADDITIONAL FOLLOW UP INDICATED NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666219 PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H| R