BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 5051329 · Received September 2, 2015

    Report

    Report Number
    3004209178-2015-17183
    Event Type
    Injury
    Date Received
    September 2, 2015
    Report Date
    August 11, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37601, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3387-40, LOT# V001236, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. 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 37601, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387-40, LOT# J0337370V, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE PATIENT THAT REPORTED FROM 2006 THROUGH 2012 THE PATIENT FELL SEVERAL TIMES EACH YEAR DUE TO DYSTONIA ISSUES WHICH CAUSED BALANCE AND COORDINATION ISSUES. SHE HAD NOT FALLEN IN 3 YEARS AS THE DEEP BRAIN STIMULATOR (DBS) HAD BEEN EFFECTIVE IN CONTROLLING THIS NOW. DURING HER FALLS SHE HAD BROKEN BONES. THEY DID NOT REMEMBER THE EXACT DATES OF EACH FALL, ONLY THE TIMELINE IN WHICH THESE FALLS STARTED AND STOPPED OCCURRING. THE PATIENT WAS IMPLANTED FOR DYSTONIA AND MOVEMENT DISORDERS. FURTHER FOLLOW-UP IS BEING CONDUCTED TO DETERMINE WHAT THE CAUSE OF THE FALLS WAS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. PLEASE SEE MANUFACTURER REPORT #3004209178-2015-17179 FOR INFORMATION ON THE PATIENT'S CONCOMITANT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581623 SOLETRA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Other