BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2012274 · Received February 2, 2011

    Report

    Report Number
    3004209178-2011-00823
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 18, 2011
    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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT FELT A BIG SHOCK AND THEN THE DEEP BRAIN STIMULATOR TURNED OFF. THE DEVICE TURNED ITSELF OFF AFTERWARD. THE PATIENT EXPERIENCED FEELING SICK AND OUT OF IT WITH EXTREME FATIGUE. SHE SPENT A LOT OF TIME IN BED. THE SYMPTOMS WERE ONGOING. THE PATIENT'S FAMILY HAD CONTACTED THE IMPLANTER FOR ABOUT 3 WEEKS AND PLANNED TO BE IN CONTACT WITH THE NEUROLOGIST. REFERENCE MFG. REPORT 3004209178201100822. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED, IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 68 YR EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# N24837A| EXPLANTED:| IMPLANTED:| LOT# NFW143699H| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7438, LOT# NHL003322P| IMPLANTED:| LEAD: MODEL 3387, LOT# J0527107V| EXTENSION: MODEL 7482, LOT# NHU093120V| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| IMPLANTED: