BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2842701 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10655
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 25, 2012
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE, SERIAL #(B)(4), FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE AFTER THE REPLACEMENT THE PATIENT WAS "WELL" AND THERE WAS NO PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT IMPROVE AFTER IMPLANT AND THE DEVICE WAS REPLACED. IT WAS STATED THAT THE STIMULATOR HAD BEEN IMPLANTED FOR 3 MONTHS BUT THE PATIENT DID NOT IMPROVE "EVEN IF THE RESPONSE WAS POSITIVE IN STIMULATING INTRA OPERATIVELY." IT WAS NOTED THAT THE IMPEDANCES WERE NORMAL AND AN X-RAY FOR VISUALIZATION SHOWED THAT THE SYSTEM WAS NORMAL "EVEN WITHOUT FRACTURE SYSTEM." THERE WAS NO INJURY. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention