BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2193606 · Received July 14, 2011

    Report

    Report Number
    3004209178-2011-05436
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    January 1, 2001
    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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED AN INTERMITTENT LOSS OF TREMOR CONTROL WHEN TRYING TO BRING SOMETHING TOWARD THE FACE AND WHEN EXTENDING THE ARMS OUTWARD WITH THE PALMS FACING EACH OTHER. THE PT'S LEFT HAND TREMOR CONTROL WAS NOT AS GOOD AS THE RIGHT HAND. THE PT RELIED ON THE RIGHT SIDE TO STABILIZE. IMPEDANCE READINGS WERE GREATER THAN 2,000 OHMS ON SOME OF THE UNIPOLAR PAIRS. AN OPEN CIRCUIT OR A FRACTURE WERE SUSPECTED AND, AS SUCH, THE PT'S DEVICE WAS PROGRAMMED AROUND THIS "FOR A WHILE." THE PT'S DEVICE WAS TO BE PROGRAMMED USING 0-1 /C-1 IN ORDER TO DETERMINE IF SYMPTOM CONTROL IS ACHIEVED. ADD'L INFO WAS REQUESTED, BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE. SEE ALSO MFR 3004209178-2011-05435.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK EXPLANTED:| PROGRAMMER: MODEL 7438, LOT # NHL005352P| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LOT # NFW142605H| EXTENSION: MODEL 748240, LOT # NGK019013N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT # J0231016V| EXTENSION: MODEL 7482, LOT # NHU152671V| EXPLANTED:| IMPLANTED:| LEAD MODEL 3387, LOT # J0309590V| EXPLANTED:| LEAD: MODEL 3387, LOT # V040724