BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3073556 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06792
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PHYSICIAN HAD DONE "THE DEVICE SKIN PACKAGE MOVEMENT," BUT THE SAME PROBLEM REMAINED. IT WAS STILL APPEARED LIKE THE WOUNDS FESTERED. THE PLAN TO DEAL WITH THIS ISSUE WAS BEING DISCUSSED. IT WAS YET TO BE DETERMINED WHETHER THE DEVICE NEEDED TO BE EXPLANTED OR NOT. THE PATIENT WAS WAITING FOR THE TREATMENT. THE ISSUE HAD NOT BEEN RESOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS CONFIRMED THAT "THE DEVICES DID NOT BE EXPLANTED OUT" AND THAT "THE ALLERGIC REASON WAS STILL UNKNOWN."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE DEVICE WAS IMPLANTED IN 2008 THE PATIENT'S SKIN APPEARED TO "FESTER". IT WAS STATED THAT THE "PHYSICIAN DOUBT PATIENT MAY ALLERGIC TO THE DEVICE". IT WAS NOT CLEAR WHAT THAT MEANT. IT WAS STATED THAT "RE-OPERATION 4 TIMES TO REVISE THE DEVICE". IT HAD STILL APPEARED THE SAME. FURTHER INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT UNDERWENT A FIFTH SURGERY TO ¿TO ADJUST THE POSITION¿. IT WAS ALSO NOTED THAT THE REASON FOR THE ALLERGIC ISSUE WAS ¿UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW UP REPORTED THE PATIENT UNDERWENT THEIR FIFTH SURGERY TO ADJUST POSITION ON (B)(6) 2013. THE PATIENT WAS CURRENTLY UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174654 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention