BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3061886 · Received April 16, 2013

    Report

    Report Number
    3004209178-2013-06374
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 30, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V893288, IMPL ANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V902325, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT THOUGHT SHE MAY HAVE HAD A STROKE/MINI STROKE DURING THE NIGHT. IT WAS REPORTED THAT 'SOMETHING' HAPPENED OVERNIGHT AND THE PATIENT HAD TROUBLE GETTING AROUND THIS MORNING. THE PATIENT PROGRAMMER DISPLAYED THE 'REPLACE PATIENT PROGRAMMER BATTERY' SCREEN. THE BATTERIES WERE CHANGED AND BOTH STIMULATORS WERE ON AND NOTED TO BE OK. THE PATIENT HAD NOT CALLED THEIR DOCTOR AT THE TIME OF THE REPORT, AS SHE WANTED TO MAKE SURE THE DEVICES WERE ON AND THE BATTERIES WERE OK. THE PATIENT PLANNED TO CONTACT THEIR DOCTOR. ADDITIONAL INFORMATION WAS REQUESTED; IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162080 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Other