BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3203533 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-11214
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Report Date
    June 6, 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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: 2011-(B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3387S-40, LOT# V113842, IMPLANTED: 2008-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40, LOT# V118075, IMPLANTED: 2008-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN. THE DEVICE WAS FUNCTIONING NORMALLY THE LAST TIME IT WAS INTERROGATED. ATTEMPTS TO GET THE PATIENT IN TO RE-INTERROGATE THE DEVICE WERE UNDERWAY. NO HOSPITALIZATION WAS REQUIRED AND THE PATIENT OUTCOME WAS NO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT BATTERY HAD NOT BEEN MAKING A CONNECTION WITH THE LEAD IN THE PATIENT¿S NECK. THE ISSUE OCCURRED IN (B)(6) OF 2013. IT WAS LATER REPORTED THAT THE PATIENT¿S HANDS WERE VERY SHAKING AND CAUSING HIM STRESS. THE PATIENT COULDN¿T FUNCTION AND COULD BARELY WRITE. IT WAS NOTED THAT THE PATIENT¿S TREMORS HAD GOTTEN WORSE AND THERE WAS A RETURN OF SYMPTOMS SOMETIME IN 2012. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304707 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR