BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3884295 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-11814
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010-, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3389-40, LOT# J0527242V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION,. PRODUCT ID: 3389-40, LOT# J0527242V, # IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_UNKNOWN_PROG. LOT# SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED ON (B)(6) 2014 THAT THE PATIENT¿S KNEES HAD BEEN ¿COLLAPSING ON HIM FOR ABOUT A WEEK,¿ BUT THE MAIN ISSUE WAS THAT HE HAD TROUBLE GETTING BACK UP. THE PATIENT HAD TROUBLE WALKING, BUT THE REPORTER NOTED HE ALWAYS HAD TROUBLE WITH BALANCE. THE REPORTER WANTED TO CHECK THE PATIENT¿S IMPLANTS TO MAKE SURE THEY WERE WORKING. BOTH SIDES SHOWED ¿ON AND OKAY.¿ ABOUT A MONTH LATER IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS COGNITIVE ISSUES AND DISEASE PROGRESSION. AN INFECTION WORKUP WAS NEGATIVE. THE PATIENT HAD HALLUCINATIONS AND WAS DELUSIONAL. THE PATIENT WAS WANDERING IN HIS HOME AND HAD A FEW FALLS DUE TO KNEES BUCKLING. THIS WAS NOT A NEW ISSUE AND THE PATIENT WAS STARTED ON QUETIAPINE. NO HOSPITALIZATION WAS REQUIRED AND THE PATIENT OUTCOME WAS MARKED AS NO INJURY. REFER TO MANUFACTURING REPORT #3004209178-2014-11813 AS THE PATIENT HAD TWO INS¿S AND IT WAS NOT INDICATED WHICH WAS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360076 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Other