BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 4153242 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18519
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387S-40, LOT# V100746, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7436, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3387S-40, LOT# V100746, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT NEEDED AN MRI OF THEIR BRAIN. THE PATIENT HAD ALTERED MENTAL STATUS AND WAS ¿ACTING CRAZY.¿ THEY WERE NOT SURE WHAT WAS WRONG OR WHAT THE REASON FOR THE MRI WAS. THEY STARTED TO HAVE THE ISSUES ON 2014 (B)(6) AND THEY ALREADY HAD A CT SCAN. IT WAS LATER REPORTED THAT THE MRI WAS RELATED TO IMPLANT. THE PATIENT HAD HAD A CHANGE IN PERSONALITY SINCE (B)(6) PRIOR TO THE DATE OF THIS REPORT AND THEY WERE WANTING TO LOOK AT A POTENTIAL ABSCESS AROUND THE SYSTEM. THE DEVICE IS OFF. NO OUTCOME WAS PROVIDED REGARDING THE EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630609 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention