BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3073062 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06766
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V585792, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 7438, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V591417, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HAD STITCHES IN THE PAST TO CLOSE THE ORIGINAL INCISION OF HER SURGERY BECAUSE IT HAD OPENED UP. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. INFORMATION ALSO REPORTED ON PATIENT'S OTHER IMPLANTABLE NEUROSTIMULATOR IN MANUFACTURER'S REPORT # 3004209178-2013-06764. REFER TO MANUFACTURER'S REPORT # 3004209178-2013-06754 FOR ADDITIONAL PATIENT AND DEVICE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174379 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention