BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3883273 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-11790
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    May 30, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-40, LOT# VA07U49, 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 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3389S-40, LOT# VA05LG5, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3389S-40, LOT# VA05LG5, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID 3389S-40, LOT# VA07U49, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-40, LOT# VA07U49, 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 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389S-40, LOT# VA05LG5, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION; PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR' PRODUCT ID 3389S-40, LOT# VA05LG5, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION; PRODUCT ID 3389S-40, LOT# VA07U49, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ELECTRICAL SHOCK FROM TOUCHING A WIRE. THERE WAS A LOSS OF STIMULATION/THERAPEUTIC EFFECT. THE PATIENT HAD TOUCHED AN ELECTRICAL LINE, FARMWIRE FOR LIVESTOCK, AND THE PATIENT WAS SHOCKED. IT WAS UNKNOWN IF ANY ACTION WAS REQUIRED AS A RESULT OF THE EVENT. IMPEDANCE TESTING WAS DONE AND SOME ELEVATIONS WERE SEEN BUT THEY WERE PRE-EXISTING. IT WAS NOTED THAT THE EVENT APPEARED TO NOT HAVE CHANGED THE IMPEDANCES. THE PATIENT WAS ALIVE WITH NO INJURY. PATIENT SYMPTOMS INCLUDED HEADACHE, PAIN, RETURN OF TREMORS BUT IT WAS NOT BELIEVED TO BE GREATER THAN 50%. IT WAS NOTED THAT PAIN WAS THE SHOCK. THE LOCATION OF ISSUE OR SYMPTOM WAS DEVICE POCKET, EXTENSION LOCATION AND LEAD LOCATION. THE SHOCK WAS FELT RUN FROM THE BATTERY ALL THE WAY INTO THE PATIENT¿S HEAD. SINCE THE EVENT THE PATIENT HAD SOME HEADACHES AND RETURN OF SYMPTOMS. ADDITIONAL INFORMATION RECEIVED REPORTED AN MRI HAD NOT BEEN ORDERED, THE PATIENT WAS WAITING TO FOLLOW UP WITH HIS HEALTHCARE PROFESSIONAL. NO OTHER INFORMATION. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S DEVICE WAS CHECKED AND EVERYTHING HAD APPEARED TO BE OPERATING AS EXPECTED AND SETTINGS/IMPEDANCES WERE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360544 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR