BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2487761 · Received March 12, 2012

    Report

    Report Number
    3004209178-2012-01486
    Event Type
    Injury
    Date Received
    March 12, 2012
    Report Date
    February 15, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3387S-40, LOT #V145259, IMPLANTED: (B)(6) 2009, EXPLANTED: NA. LEAD: MODEL 3387S-40, LOT #V145259, IMPLANTED: (B)(6) 2009, EXPLANTED: NA. EXTENSION: MODEL 7482A40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: NA. EXTENSION: MODEL 748266, SERIAL # (B)(4), IMPLANTED: (B)(4) 2009, EXPLANTED: NA. NEUROSTIMULATOR: MODEL 7426, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: NA. LEAD: MODEL 3387S-40, LOT #V130906, IMPLANTED: (B)(6) 2009, EXPLANTED: NA. LEAD: MODEL 3387S-40, LOT #V130906, IMPLANTED: (B)(6) 2009, EXPLANTED: NA. EXTENSION: MODEL 7482A40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN "EMERGENCY" WITH A LOSS OF THERAPEUTIC EFFECT AND A RETURN OF THEIR TREMOR ON THEIR LEFT SIDE. IT WAS NOTED THAT, RECENTLY, THE STIMULATION WAS INTERMITTENTLY TURNING OFF. THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR WAS CHECKED APPROXIMATELY A MONTH AGO AND WAS DETERMINED TO BE "OKAY." IT WAS NOTED THAT THE PATIENT DID HAVE RADIATION SEEDS IMPLANTED IN HIS PROSTATE IN (B)(6) 2011. 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 MDT PUERTO RICO OPERATIONS CO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention