BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1893252 · Received November 3, 2010

    Report

    Report Number
    3004209178-2010-08796
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 11, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SEE ALSO MFR REPORT # 3004209178201008794. IT WAS REPORTED THAT THE PT FELT NUMBNESS ON THE LEFT SIDE OF THE BODY, "ON AND OFF," FOR THE PAST MONTH. THE PT HAD FALLEN "A LOT," BUT DID NOT SEEK MEDICAL ATTENTION FOR THESE EVENTS. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFO WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADDITIONAL INFO 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 51 YR EXTENSION: MODEL 7482, LOT# NHU086486V| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| UNK CONVERSION TYPE: MODEL DBSLEAD, LOT# UNK| UNK CONVERSION TYPE: MODEL DBSLEAD, LOT# UNK| IMPLANTED:| EXTENSION: MODEL EXTENSION, LOT# UNK| IMPLANTED:| IMPLANTED:| EXPLANTED:| LOT# *UK6138500| EXPLANTED:| EXPLANTED:| EXPLANTED:| LOT# NFW164071H| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL EXTENSION, LOT# UNK| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7438, LOT# NHL009420P| IMPLANTED:| UNK CONVERSION TYPE: MODEL DBSLEAD,