BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3162946 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10156
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 21, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 7438, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3387-40, LOT# V007376, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 3387-40, LOT# V007376, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYMPTOM OF SPASTICITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S BATTERY ¿ONLY LASTED TWO YEARS AND ONE MONTH WHEN THEIR LAST BATTERY LASTED FOUR AND A HALF YEARS.¿ IT WAS NOTED THE PATIENT WAS SCHEDULED TO HAVE THEIR LEFT DEVICE REPLACED THE FOLLOWING WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262714 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention