BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3422843 · Received October 22, 2013

    Report

    Report Number
    3004209178-2013-19470
    Event Type
    Injury
    Date Received
    October 22, 2013
    Report Date
    October 3, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V052560, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT# V014497, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS NOTED THAT THE PATIENT WAS NOT SEEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEUROSTIMULATOR (INS) WAS TURNED OFF ABOUT A YEAR AGO BECAUSE THE PATIENT FELL DOWN, HIT HER HEAD AND WAS IN A CAREGIVER FACILITY. IT WAS ADDED THAT PATIENT INS WAS TURNED OFF BECAUSE PATIENT HAD A BLOOD CLOT ON HER BRAIN. IT WAS NOTED THAT PATIENT HAD BEING SEEING A NEUROLOGIST AND HE ADJUSTED IT AND TURNED IT BACK ON. A FOLLOW-UP REPORT WILL BESENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NOT FOLLOWED UP WITH THEIR OFFICE SINCE 2012 (B)(6). IT WAS NOTED THAT THE PATIENT THAT THE OFFICE HAD NOT SEEN THE PATIENT SINCE THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541016 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Other