BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 4243676 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21328
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    October 21, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANT THE PATIENT¿S SYMPTOMS AND PAIN HAD NOT IMPROVED. THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) TOLD THEM THEIR PAIN AND SYMPTOMS WOULD BE RELIEVED. (B)(6) 2012 THE PATIENT WAS IN THE HOSPITAL AND THEY STILL HAD SYMPTOMS AFTER BEING REPROGRAMMED SEVERAL TIMES. THE PATIENT WAS REPROGRAMMED AGAIN IN (B)(6) 2012, BUT THE SYMPTOMS HAD NOT IMPROVED. (B)(6) 2013 THE PATIENT CONTINUED TO SEE THEIR HCP, BUT THEY DID NOT HAVE A METHOD TO HELP THE PATIENT. IN (B)(6) 2013 THE PATIENT SAW THEIR HCP AND THEY TOLD THEM TO TAKE OXCARBAZEPINE TO TREAT THE PATIENT¿S SPASM. AFTER TAKING THE MEDICATION, THE PATIENT FELT MORE PAIN SO THEY STOPPED TAKING IT. SINCE (B)(6) 2013, THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN OFF AND THE PATIENT¿S PAIN WAS RELIEVED. THE PATIENT¿S ¿PROBLEM OF WALKING¿ AND COMA HAD NOT OCCURRED AGAIN. THE PATIENT DID HAVE TO TAKE SLEEPING PILLS TO SLEEP AND THEY WANTED TO BE REPROGRAMMED AGAIN. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727539 SOLETRA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization| O