BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3910132 · Received July 2, 2014

    Report

    Report Number
    3004209178-2014-12445
    Event Type
    Injury
    Date Received
    July 2, 2014
    Report Date
    June 10, 2014
    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 MEDICAL PRODUCTS: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387S-40, LOT# V296972, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387S-40, LOT# V268107, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 7438, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN INFECTION. IT WAS NOTED THE RIGHT INS WAS LAST CHECKED AND ¿JUICE WAS TURNED UP ON IT¿ IN (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386422 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention