BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2951356 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01507
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 16, 2012
    Report Date
    January 21, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V010793, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT# J0519620V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THEIR TEETH REMOVED IN (B)(6) 2012. IT WAS NOTED THAT THE PATIENT FELT LIKE "IT HAD DONE SOMETHING TO THEM". IT WAS UNCLEAR WHAT TYPE OF EQUIPMENT, OR OTHER ACCESSORIES THE DENTIST USED AND IF THAT AFFECTED THE PATIENT'S DEVICE. THE PATIENT'S SPEECH WAS REPORTED AS "OFF". IT WAS ALSO UNCLEAR IF THAT WAS DEVICE RELATED OR NOT. IT WAS NOTED THE "THING WAS OFF". IT WAS UNCLEAR IF THIS WAS REFERRING TO THE DEVICE OR SOMETHING ELSE. IT WAS INDICATED THE PATIENT HAD AN APPOINTMENT WITH THEIR HEALTHCARE PROVIDER IN (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED. REFER TO MANUFACTURER REPORT #3004209178-2013-01506. THE PATIENT HAS TWO DEVICES AND IT WAS UNCLEAR IF THE REPORTED EVENT PERTAINED TO ONE OR BOTH OF THE PATIENT'S DEVICES.

    Description of Event or Problem · 1

    THIS WAS A BILATERAL SYSTEM. REFERENCE MFR 3004209178-2013-01506.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56284 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR