BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2573804 · Received May 15, 2012

    Report

    Report Number
    3004209178-2012-03276
    Event Type
    Injury
    Date Received
    May 15, 2012
    Report Date
    April 18, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    EXTENSION MODEL 7482A51, SERIAL# (B)(4), IMPLANTED: 2011-(B)(6), EXPLANTED: NA, LEAD MODEL 3387S-40, LOT #V553427, IMPLANTED: 2011-(B)(6), EXPLANTED: NA, CONCOMITANT INS SYSTEM: NEUROSTIMULATOR MODEL 7426, SERIAL #(B)(4), IMPLANTED: 2011-(B)(6), EXPLANTED: NA, EXTENSION MODEL 7482A51, SERIAL #(B)(4), IMPLANTED: 2011-(B)(6), EXPLANTED: NA. LEAD MODEL 3387S-40. LOT #V553427, IMPLANTED: 2011-(B)(6), EXPLANTED: NA. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED INDICATED THAT THE CAUSE OF THE EVENT WAS "PRIMARY GENERALIZED DYT-1 DYSTONIA." IT WAS NOTED THAT THE PATIENT WAS DOING WELL AND THAT THERE WAS NO HOSPITALIZATION DUE TO THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DYSTONIA IN THEIR RIGHT LEG HAS WORSENED SINCE GETTING IMPLANTABLE NEUROSTIMULATOR (INS) AND WAS NOW BACK IN A WHEELCHAIR. IT WAS NOTED THAT THE INS WAS IMPLANTED FOR DYSTONIA IN THE PATIENT'S LEFT LEG AND WAS MUCH BETTER FOR THAT AREA OF THE BODY. REPROGRAMMING WAS CONTINUING AND A MRI MAY BE NEEDED TO DETERMINE IF THE LEAD PLACEMENT IN THE BRAIN COULD BE A CONCERN. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention