BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2990969 · Received March 6, 2013

    Report

    Report Number
    3007566237-2013-00686
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT'S DERMATOLOGIST BELIEVED THAT THE PATIENT DID NOT HAVE AN ALLERGY OR AN INFECTION. THE PHYSICIAN PLANNED TO DO SOME ALLERGY TESTS SOON.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE SYMPTOMS WERE REDNESS, PAIN AND ITCHING AT THE SITE OF IMPLANT. THERE WERE NO SIGNS OF INFECTION OR SWELLING. THE AREA RESPONDED TO ANTIHISTAMINES. THE SURGEON DID NOT TAKE ANY TISSUE SAMPLES. THE SITE OF IMPLANT WAS CHANGED (B)(6) 2011 AND AGAIN IN (B)(6) 2012. ALLERGY TESTS WERE SUGGESTED. AN OUTCOME WAS NOT PROVIDED. IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAD BEEN AN ALLERGIC REACTION/EROSION. AN INFLAMMATORY REACTION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE WAS NOTED WITHOUT ANY LOCALIZED INFECTION. IT WAS UNCLEAR IF THIS WAS AN ALLERGY TO THE INS MATERIAL. IT WAS STATED THAT THE INS SITE HAD BEEN CHANGED 3 TIMES OVER THE PAST 18 MONTHS AND THE INFLAMMATORY RESPONSE CAME BACK EACH AND EVERY TIME. PATIENT STATUS AT THE TIME OF THIS REPORT WAS NOT POSSIBLE TO BE OBTAINED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96066 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention