BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2305317 · Received October 24, 2011

    Report

    Report Number
    3004209178-2011-08939
    Event Type
    Malfunction
    Date Received
    October 24, 2011
    Date of Event
    June 15, 2007
    Report Date
    April 19, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXTENSION MODEL 7482A51, (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2007. EXTENSION MODEL 7482A51, (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2007. EXTENSION MODEL 7482A51, (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2007. EXTENSION MODEL 7482A51, (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2007. EXTENSION MODEL 7482A51, (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: UNK. EXTENSION MODEL 7482A51, (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: UNK. LEAD MODEL 3387S-40, LOT# V021585, IMPLANTED: (B)(6) 2007, EXPLANTED: UNK. LEAD MODEL 3387S-40, LOT# V020895, IMPLANTED: (B)(6) 2007, EXPLANTED: UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH EXTENSIONS FRACTURED DURING TUNNELING. THE FRACTURES WERE THOUGHT TO BE RELATED TO THE PATIENT'S FASCIA, WHICH WAS NOTED TO BE THICKER THAN NORMAL. THE NEUROSURGEON USED EXTRA FORCE TO TUNNEL THROUGH THE THICK FASCIA DURING THE IMPLANT AND BOTH EXTENSIONS FRACTURED TWICE. THE EXTENSIONS WERE REPLACED AND THE PATIENT OUTCOME WAS REPORTED AS RESOLVED WITHOUT SEQUELA. THE PATIENT DID NOT SUFFER ANY SYMPTOMS DUE TO THE EVENT. IT WAS ALSO REPORTED THAT THE PATIENT'S BATTERY LATER DEPLETED AND WAS REPLACED. THE PATIENT OUTCOME WAS REPORTED AS RESOLVED WITHOUT SEQUELA.

    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 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR