BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2882440 · Received December 20, 2012

    Report

    Report Number
    3004209178-2012-12118
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    July 30, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 7438, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389-40, LOT # J0222890V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 3389-40, LOT # J0217096V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A SPINAL FUSION ON (B)(6) 2012. THE PROCEDURE WAS UNRELATED TO THE DEVICE. THE REPORTER STATED THAT THE PATIENT "WAS MOVING" AND THOUGHT SOMETHING CHANGED AFTER SURGERY. IT WAS NOTED THAT THE REPORTER WANTED TO HAVE THE DEVICE CHECKED. THE REPORTER STATED THAT BEFORE SURGERY, THERE WAS NOT A MANUFACTURING REPRESENTATIVE TO TURN THE SYSTEM DOWN AND OFF. THE REPORTER STATED THAT THE DEVICE WAS TURNED OFF WITH THE PATIENT PROGRAMMER BEFORE SURGERY. IT WAS REPORTED THAT THE PATIENT WAS STILL AT THE HOSPITAL AND THE REPORTER FELT THAT IT WOULD IMPEDE HIS RECOVERY IF HIS SETTINGS WERE OFF. THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE REPORTER STATED THAT THE PATIENT WAS "VERY PARKINSONISM" AND WASN'T MOVING AS HE NORMALLY DID WHEN THE SETTINGS WERE ON. IT WAS REPORTED THAT WHEN THE DEVICE WAS TURNED BACK ON ALL THE STATUS LIGHTS CAME ON, BUT THE REPORTER HAD NO WAY TO KNOW ABOUT THE PATIENT'S PROGRAMMED SETTINGS WITHOUT A CLINICIAN CHECKING IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. SEE MFR REPORT # 3004209178-2012-12117 IT WAS UNCLEAR WHICH DEVICE WAS PART OF THE EVENT OR IF BOTH DEVICES WERE PART OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS NOTED THAT WHEN THE DEVICE WAS TURNED BACK ON AFTER SURGERY, IT WAS CONCERNS THAT THE SETTINGS MAY HAVE BEEN CHANGED. IT WAS ALSO NOTED THAT THE PATIENT SHOWED SOME DYSKINESIA AFTER TAKEN MEDICATION, BUT PATIENT HASN¿T SHOWN ANY SIGNS OF DYSKINESIA AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1