BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3173736 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10467
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387-40, LOT# J0225593V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 748266, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT# J0228090V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT# J0225593V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 748266, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT# J0228090V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ONE OF THE PATIENT¿S IMPLANTABLE NEUROSTIMULATORS (INS) WAS OFF; INITIALLY THE LEFT INS WAS OFF AND THE RIGHT INS WAS ON BUT DURING TROUBLESHOOTING IT WAS ¿SHOWING THE OPPOSITE OF WHAT IT DID BEFORE.¿ THE PATIENT¿S SPOUSE WAS ABLE TO TURN THE RIGHT DEVICE ON AND CONFIRMED THE LEFT DEVICE WAS ON. NO PATIENT SYMPTOMS WERE REPORTED. REFER TO MANUFACTURER REPORT # 3004209178-2013-10465.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273183 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR