BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3112213 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07638
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    May 2, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: EXTENSION: PRODUCT ID 3389-40, LOT# J0222890V, IMPLANTED: (B)(6) 2002. PRODUCT TYPE: LEAD: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: EXTENSION: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3389-40, LOT# J0217096V, IMPLANTED: 2002-10-22 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 7438 LOT# SERIAL# NHL018361P IMPLANTED: (B)(6) 2007. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCE MEASUREMENTS OVER 2,000 OHMS WERE SEEN ON SOME OF THE UNIPOLAR PAIRS. CONTACT #3, WHICH THE PATIENT NEEDED FOR THERAPY, WAS SHOWING OVER 2,000 OHMS AND UNDER 7 MA. IT WAS ALSO REPORTED THAT THE PATIENT WAS "ACUTELY WORSE" AND HAD REPORTED FALLS. THE HCP BELIEVED THAT THE FALLS MIGHT BE DUE TO THE WORSENING SYMPTOMS. IT WAS NOTED THAT THE LAST TIME THE PATIENT¿S LEFT INS WAS CHECKED EVERYTHING HAD BEEN FINE. THERE WERE NO ISSUES WITH THE RIGHT INS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212356 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1