BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3167892 · Received June 13, 2013

    Report

    Report Number
    3004209178-2013-10297
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Report Date
    May 30, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    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 # V012773, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT # V010293, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS ¿ARBITRARILY SHUT OFF¿ SEVERAL YEARS AGO AND THE PATIENT WAS ABLE TO TURN IT BACK ON. ABOUT A MONTH PRIOR TO THE DATE OF THIS REPORT, THE DEVICE ¿SHUT OFF¿ AGAIN AND THE PATIENT WAS ABLE TO TURN IT BACK ON. THE PATIENT DID NOT KNOW WHAT CAUSED THE DEVICE TO TURN OFF. IT WAS REPORTED THAT THE PATIENT HAD COLD LASER PAIN THERAPY WHERE HE APPLIES A LASER TO THE LUMBER SPINE IN THE LOWER BACK. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT ¿RECEIVED ASSISTANCE FROM THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED.¿ IT WAS STATED THE PATIENT ¿NEEDED TO KNOW IF HE COULD HAVE LASER THERAPY ON A PAINFUL JOINT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269419 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR