BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 1850877 · Received September 28, 2010

    Report

    Report Number
    3004209178-2010-07400
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3387S-40, LOT# V007141, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V007141, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED STIMULATION IN THE WRONG LOCATION. WHILE THE DEVICE WAS ON, THE PT COULD NOT USE HER LEFT HAND DUE TO THE PLACEMENT OF THE LEAD. THE OTHER LEAD WAS OK BUT NOT OPTIMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE MADE AS F/U AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE GOOD RESULTS ORIGINALLY. IT WAS NOTED THAT THE RIGHT BRAIN LEAD WAS REPLACED BECAUSE THE ORIGINAL PLACEMENT WAS NOT GIVING HER TREMOR CONTROL ON THE LEFT HAND. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention| S EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU132313V| IMPLANTED:| LEAD: MODEL 3387S, LOT# V007141| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU132312V| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT# V007141| IMPLANTED: