BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 5080986 · Received September 16, 2015

    Report

    Report Number
    3004209178-2015-18090
    Event Type
    Injury
    Date Received
    September 16, 2015
    Report Date
    August 21, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V093181, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT A PATIENT WHOSE INDICATION FOR USE IS ESSENTIAL TREMOR AND MOVEMENT DISORDERS HAD A DECLINE IN HEALTH AND DEEP BRAIN STIMULATION AFTER 2ND DEEP BRAIN STIMULATOR SURGERY. THE PATIENT HAD GONE HOME AFTER SURGERY AND HAD A SEIZURE WHICH THEY THOUGHT WAS IN 2010. THERE WAS A FALL THAT COULD BE RELATED TO THE ISSUE. THE PATIENT HAD BEEN FALLING FOR THE LAST COUPLE OF YEARS. THE PATIENT WAS IN REHAB. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN INFORMATION ABOUT TROUBLESHOOTING PERFORMED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613472 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Other