BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3893537 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-12002
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 20, 2014
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT# VA072E3, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# VA077AS, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT# VA072E3, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# VA077AS, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HEALTHCARE PROFESSIONAL OR MANUFACTURING REPRESENTATIVE AND HAD AN APPOINTMENT ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR THE LAST COUPLE OF DAYS THE PATIENT¿S MEDICATION WAS NOT EVEN EFFECTIVE. THE PATIENT STATED THAT HER SYMPTOMS RETURNED THE DAY PRIOR TO THE REPORT. THE PATIENT NOTED THAT SHE JUST WOKE UP THE DAY PRIOR TO THE REPORT AND NEVER REALLY GOT ANY RELIEF ALL DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372016 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1