BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3072937 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06757
    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

    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. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEGS HAD BEEN VERY "SHAKY" FOR THE 2-3 WEEKS PRIOR TO THE REPORT. THE PATIENT ADDITIONALLY HAD INCREASED TREMOR IN HER RIGHT HAND WHICH WAS NOTED TO OCCUR WITH STRESS. THESE TREMORS WERE NOTED TO HAVE GONE AWAY IN THE PAST BUT SEEMED TO HAVE BEEN HAPPENING "MORE FREQUENTLY". THE REPORTER STATED THAT THE PATIENT FELL ON CEMENT ABOUT A WEEK PRIOR TO THE REPORT AND HIT HER HEAD. ON THE THURSDAY PRIOR TO THE REPORT, THE PATIENT HAD STITCHES TO CLOSE THE ORIGINAL INCISION OF HER SURGERY BECAUSE IT OPENED UP. IT WAS UNCLEAR IF THIS WAS AS A RESULT OF THE FALL OR DUE TO SOME OTHER ISSUE. HOWEVER, THERE WAS NO KNOWN ACCIDENT RELATED TO THE PATIENT'S SYMPTOMS AS THE SYMPTOMS WERE INDICATED TO HAVE BEEN PRESENT BEFORE THE FALL. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT SCHEDULED WITH A MANUFACTURER'S REPRESENTATIVE TO HAVE HER SYSTEM READJUSTED. 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 # 3004209178-2013-06754.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173275 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention