BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3854112 · Received June 6, 2014

    Report

    Report Number
    9614453-2014-01064
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    July 1, 2010
    Report Date
    June 6, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MFR
    PMA / PMN Number
    H050003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7428, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3391-28, LOT# 0203871780, IMPLANTED: 2010-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID NEU_UNKNOWN, LOT# 0203871798, IMPLANTED: 2010-(B)(6), PRODUCT TYPE UNKNOWN. PRODUCT ID 7428, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A MAJOR INTERMITTENT DEPRESSIVE EPISODE. THE PATIENT HAD ANHEDONIA, WORSENED MOOD, DISAPPOINTED THOUGHTS, SUICIDAL THOUGHTS, SLEEPING PROBLEMS AND A LESSENED APPETITE. INTERVENTION INVOLVED REPROGRAMMING. THE EVENT WAS NOTED AS RESOLVED WITHOUT SEQUELAE. ADDITIONAL INFORMATION REPORTED THE PATIENT HAD NERVOUSNESS. IT WAS REPORTED THE PATIENT HAD FATIGUE AND WAS FEELING TIRED THE FIRST DAYS AFTER REPROGRAMMING. NO ACTION HAD BEEN TAKEN. THE EVENT WAS NOTED AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE IMPLANT PROCEDURE. THE EVENT WAS NOTED AS RESOLVED WITHOUT SEQUELAE. ADDITIONAL INFORMATION REPORTED REPROGRAMMING RESULTED IN THE NERVOUSNESS DISAPPEARING. ADDITIONAL INFORMATION NOTED THE DEVICE WAS REPROGRAMMED AGAIN. SEE MANUFACTURER REPORT # 9614453-2014-01063 PATIENT HAS BILATERAL SYSTEMS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330861 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MFR IPG MFG SWITZERLAND 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Other