BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1842023 · Received September 21, 2010

    Report

    Report Number
    3004209178-2010-07123
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 5, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED TO TREAT THE SYMPTOMS OF THALAMIC STROKE. THE PATIENT FELL AND HIT HER HEAD IN (B)(6) 2010. ON (B)(6)2010, THE PATIENT WAS HOSPITALIZED FOR FEVER, PNEUMONIA, FLUID AROUND HER HEART, AND SWEATING PROFUSELY. SHE WAS DISCHARGED TO HOME AND FELT BETTER WITH THE DBS SYSTEM OFF. IN (B)(6) 2010, THE PATIENT WAS WALKING BY A NEW MEDICAL CLINIC AND SOMETHING CAUSED THE DBS (DEEP BRAIN STIMULATION) TO BE TURNED ON WHEN IT WAS OFF. THE PATIENT EXPERIENCED STIMULATION IN THE WRONG LOCATION; SHE FELT "ELECTRICAL IMPULSES" THAT DID NOT FEEL RIGHT AND SHE ALSO EXPERIENCED ATAXIA, TROUBLE TALKING/UNDERSTANDING, DOUBLE VISION, AND WAS "JOLTED BACKWARDS". THE NEUROLOGIC SYMPTOMS SUBSIDED WHEN THE DBS WAS TURNED BACK OFF. THE PATIENT WAS AT HOME. SHE STILL HAD NECK PAIN, A HEADACHE, AND A LOW GRADE FEVER. IT WAS NOTED THAT SHE HAD A SEIZURE DISORDER SINCE IMPLANT. FOLLOW-UP WITH THE PATIENT'S PHYSICIAN WAS RECOMMENDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. SEE ALSO MANUFACTURER'S REPORT # 3004209178-2010-07122.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other IMPLANTED:| LOT# NFW157086H| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER: LOT# UNK| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387S, LOT# V230715| EXTENSION: MODEL 7482A51, LOT# NHU203028V| LEAD: MODEL 3387S, LOT# V230715| EXPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU203029V