BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2997605 · Received March 11, 2013

    Report

    Report Number
    3004209178-2013-03551
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Report Date
    February 18, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V972376, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# V972376, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT LIKE HER DEVICE WAS 'GOING ON AND OFF.' IT WAS STATED THAT THE PATIENT REPORTED HAVING INTERMITTENT OVERSTIMULATION SENSATIONS. IT WAS NOTED THAT THE PATIENT WENT TO THE DOCTOR ON (B)(6) 2013 AND THE DOCTOR 'CHECKED EVERYTHING AND IT LOOKED FINE.' IT WAS STATED THAT THE WEEKEND PRIOR TO THIS REPORT, IT WAS 'REALLY BAD' AND THE PATIENT HAD TO GO TO THE EMERGENCY ROOM. IT WAS NOTED THAT THE PATIENT TURNED HER DEVICE DOWN TO '2.3 AND 2.6.' IT WAS STATED THAT THE PATIENT 'CANNOT FEEL IT NOW BUT HAS A LITTLE MORE TREMOR COMING BACK.' THE PATIENT WAS REDIRECTED TO THEIR HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT "DID NOT HAVE CONCERNS WITH HER DEVICE OR THERAPY." IT WAS ALSO REPORTED THAT THE PATIENT "RECEIVED ASSISTANCE FROM HER DOCTOR OR MANUFACTURER REPRESENTATIVE AND HER CONCERNS WERE RESOLVED" AND THAT THE PATIENT WAS "STILL HAVING CONCERNS REGARDING HER DEVICE OR THERAPY, BUT SHE WAS WORKING WITH HER DOCTOR." NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. PLEASE SEE MFR. REPORT # 3004209178-2013-03552 FOR INFORMATION ON THE PATIENT'S OTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102212 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1