BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3489192 · Received November 26, 2013

    Report

    Report Number
    3004209178-2013-21466
    Event Type
    Injury
    Date Received
    November 26, 2013
    Date of Event
    November 4, 2012
    Report Date
    November 6, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7426, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 748240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT # V003289, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT # V003289, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 748240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 7438, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD BEEN POSITIVE FOR CLAUDICATION, CONSTIPATION, JOINT PAIN, SPEECH CHANGE, AND MEMORY LOSS. IT WAS STATED THAT AFTER THE PATIENT HAD LOST CONSCIOUSNESS, SHE WAS HOSPITALIZED. IT WAS NOTED THAT THE PATIENT HAD RECOVERED WITHIN 24 HOURS. IT WAS REPORTED THAT BOTH OF THE PATIENT'S DEEP BRAIN STIMULATION (DBS) UNITS WERE WORKING PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT INTO A COMA LIKE STATE AND WAS TOTALLY NON-RESPONSIVE. THIS OCCURRED RIGHT BEFORE THE PATIENT WAS TO GET HER BLOOD PRESSURE CHECKED BY THE NURSE AT A PRIMARY CARE PRACTICE. IN ORDER TO WAKE THE PATIENT BACK UP, THEY TURNED OFF THE STIMULATOR WITH THE PATIENT PROGRAMMER AND SLOWLY (15-20 MINUTES) THE PATIENT ¿BECAME¿ NORMAL. WHEN THE IMPLANT WAS TURNED OFF THE PATIENT¿S DYSKINESIA STARTED TO RETURN. JUST PRIOR TO THE EVENT, THE IMPLANT WAS ON. WHEN THE IMPLANT WAS TURNED OFF, THE PATIENTS EYELIDS TREMBLED AND THEN SHE HAD SOME MINOR DYSKINESIA. THE PATIENT¿S BLOOD PRESSURE AND HEART RATE WAS DONE, AND THE BLOOD PRESSURE WAS REPORTED TO BE 130/80. THE PATIENT WAS MASSAGED AS WELL TO TRY AND AROUSE HER. THE PATIENT HAD A NEUROLOGY APPOINTMENT 2 WEEKS AFTER THE REPORT. IT WAS STATED THAT THIS OCCURRED APPROXIMATELY ONE YEAR AGO AS WELL WHILE THE PATIENT WAS WATCHING TELEVISION. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT. SEE ALSO MFR 3004209178-2013-21464 FOR THE PATIENTS SECOND DEVICE REPORT (BILATERAL DEVICES).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN DID A "FULL WORK UP AND A CAUSE WAS NOT DETERMINED." IT WAS NOTED THAT EEG, ECG AND MRI WERE PERFORMED. IT WAS NOTED THAT A SLIGHT CHANGE WAS MADE IN THE PATIENT'S SETTINGS AND THE PATIENT WAS KEPT ON THE SAME ORAL MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614909 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| O