BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3180511 · Received June 20, 2013

    Report

    Report Number
    3007566237-2013-02040
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7426, SERIAL# (B)(6) IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEURO STIMULATOR. PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7438, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 748266, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2006,PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# J0343813V, IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2006, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2006, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387-40, LOT# J0343813V, IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7426. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TROUBLE IN THE PAST WHERE THE DEVICE WOULD SHUT OFF. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATORS WERE THREE TO FOUR INCHES AWAY FROM EACH OTHER AND WOULD INTERFERE FROM BEING SO CLOSE. IT WAS FURTHER NOTED THAT WALKING BY A MAGNETIC DETECTOR HAD AN EFFECT. SEE MFR #3007566237-2013-02039 FOR THE PATIENTS OTHER DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW REPORTED THAT THE PATIENT CHECKED THE DEVICE WITH THE PATIENT PROGRAMMER WHEN HE WAS DRIVING AND NOTICED THAT THE DEVICE WAS OFF. IT WAS NOTED THAT THIS HAPPENED ¿QUITE A BIT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281138 SOLETRA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR