BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2193303 · Received July 13, 2011

    Report

    Report Number
    3004209178-2011-05397
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 20, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN STIMULATION WAS TURNED ON AN OVERSTIMULATION SENSATION OCCURS. IT WAS REPORTED THAT THE PT CAN "FEEL THE STIM ON EACH SIDE WORKING." PT WAS CONCERNED THAT WHEN SHE EXPERIENCED PAIN THAT THE DBS SYSTEM WAS RESETTING ITSELF TO A HIGHER SETTING. PT WAS REPROGRAMMED IN (B)(6) 2011 AND WAS DUE TO BE REPROGRAMMED IN (B)(6) 2011. IT WAS REPORTED THAT THE STIMULATION HAD BEEN OFF FOR (B)(6). PT REPORTED SHE EXPERIENCED A FALL OUT OF HER WHEELCHAIR (TIMEFRAME NOT CONFIRMED) AND THE SHE EXPERIENCED GROIN PAIN AND AN OVERSTIMULATION SENSATION. PT ALSO REPORTED THAT THE STIMULATION WAS AFFECTING HER ABILITY TO BREATHE ABOUT (B)(6) AGO. IT WAS REPORTED THAT THE PT PREVIOUSLY USED STIM 24/7 BUT THEN THE DBS CAUSED MORE PROBLEMS THAN RELIEF FROM THE DYSTONIA. IT WAS REPORTED THAT THE PT WAS ADMITTED TO THE HOSP TO HAVE A SCOPE ON (B)(6) 2011 TO DETERMINE IF HER GALLBLADDER NEEDED TO BE REMOVED. ADD'L INFO HAS BEEN 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 MHY MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387S, LOT #V371989| EXPLANTED:| PROGRAMMER: MODEL 7436, LOT #NFU026683P| LEAD: MODEL 3387S, LOT #V441615| EXPLANTED:| EXTENSION: MODEL 7482A51, LOT #NHU211660V| EXTENSION: MODEL 7482A51, LOT #NHU211624V| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED: