BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATTRIX

    MDR report key: 1011283 · Received March 11, 2008

    Report

    Report Number
    2182207-2008-01200
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    January 1, 1999
    Report Date
    February 11, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    GZF
    PMA / PMN Number
    K934065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT'S DAUGHTER REPORTED THE SYSTEM HAD BEEN REPLACED DUE TO AN INFECTION. SPECIFIC PT SYMPTOMS OR TREATMENT RECEIVED IN 1999 WERE NOT PROVIDED. THE HCP REPORTED THE PT HAD RECEIVED TREATMENT WITH IV ANTIBIOTICS AND THE SYSTEM HAD BEEN EXPLANTED. THE HCP CONFIRMED THE PT HAD ANOTHER SYSTEM IMPLANTED AT A LATER DATE. SPECIFIC SYMPTOMS WERE NOT REPORTED BUT THE PT HAD BEEN FOLLOWED BY AN INFECTION CONTROL SPECIALIST AT THE TIME OF ONSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATTRIX GZF/GZB GZF MEDTRONIC NEUROMODULATION 3272 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| LEAD MODEL 3887| EXPLANTED| LEAD MODEL 3887