BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2553897 · Received April 30, 2012

    Report

    Report Number
    3004209178-2012-02807
    Event Type
    Malfunction
    Date Received
    April 30, 2012
    Report Date
    April 13, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYP EXTENSION, PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYP EXTENSION, PRODUCT ID 3389S-40, LOT# V050299, IMPLANTED: 2008 (B)(6), PRODUCT TYP LEAD, PRODUCT ID 3389S-40, LOT# V038036, IMPLANTED: 2008 (B)(6), EXPLANTED: PRODUCT TYP LEAD. PRODUCT ID 7426, SERIAL # (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYP NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT STIM WAS NOT WORKING. THE PATIENT BELIEVED HE MAY NEED TO HAVE IT ACTIVATED. THE PT MOVED FROM CA TO AZ (DUE TO SPEECH BARRIER, NEW ADDRESS COULD NOT BE OBTAINED). THE PATIENT HAD A NEW PHYSICIAN THE PATIENT HAD LOST HIS RECHARGER. PT WAS ADVISED TO HAVE HIS PHYSICIANS OFFICE CONTACT MANUFACTURER SO WE COULD HAVE A NO-CHARGE REPLACEMENT SENT TO THE MD OFFICE FOR HIM TO PICK UP. THE PATIENT PLANNED TO CALL BACK WITH SHIPPING INFORMATION FOR NEW PROGRAMMER. IT WAS REQUESTED THAT THE HEALTHCARE PROVIDER CALL MANUFACTURER DUE TO SPEECH BARRIER. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. SEE ALSO MANUFACTURER'S REPORT # 3004209178-2012-02804.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1