BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3221028 · Received July 11, 2013

    Report

    Report Number
    3004209178-2013-11620
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    June 19, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3387S-40, LOT# UNKNOWN, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 7438, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND THE STIMULATION WAS TURNING OFF. IT WAS STATED THE EVENT OCCURRED FOLLOWING A CT SCAN, HOWEVER, IT WAS NOT KNOWN IF THE STIMULATION WAS TURNED OFF PRIOR TO THE CT SCAN OR NOT. IT WAS NOTED THE PATIENT RECEIVED GOOD THERAPY PRIOR TO CT SCAN BUT HAD SOME TREMOR PRIOR TO CT SCAN AND WAS UNSURE WHEN IT STARTED. REPORTEDLY THE CT SCAN WAS FOR A CARDIAC STENT PLACEMENT AND THE TREMOR WAS ON THE LEFT SIDE OF THE BODY. WHEN STIMULATION WAS TURNED ON AGAIN ON THE DAY OF REPORT THE PATIENT FELT SHE STILL HAD SOME TREMOR ALTHOUGH SHE WAS GETTING GOOD THERAPY. IT WAS STATED THE PATIENT FELT A JOLT WHEN TURNING STIMULATION BACK ON, BUT IT ONLY OCCURRED WHEN TURNING STIMULATION BACKON AND REPORTED NOT FEELING ANY JOLTING BY THE END OF THE CALL. IT WAS ALSO MENTIONED THERE WERE HIGH IMPEDANCE READINGS AND THE REPRESENTATIVE PLANNED TO BRING UP THE PATIENTS VOLTAGE FOR PROGRAMMING AND SEE HOW SHE DOES. ADDITIONAL INFORMATION STATED THERE WERE NO MALFUNCTIONS WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS STATED INTERVENTION WAS SLOWLY INCREASING THE PATIENT¿S VOLTAGE TO THE DESIRED SETTINGS. IT WAS STATED THE PATIENT WAS DOING REALLY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319501 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1