BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3181562 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10680
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    June 3, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40 LOT# V199170, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40 LOT# V098699, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7426 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S DEVICE WAS SHUT OFF BY A MAGNET. IT WAS STATED, THE PATIENT¿S HAND WAS OVERACTIVE AND WHEN THE DEVICE WAS TURNED BACK ON THE SYMPTOMS STOPPED. [OMITTED INFORMATION FROM RELATED PES (B)(4)-FALL, LEAD EXPOSED AND (B)(4)-INFECTION @LEAD SITE].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281909 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR