BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3113350 · Received May 15, 2013

    Report

    Report Number
    3004209178-2013-07680
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    April 25, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3389-40, LOT# J0340570V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD FELT "SHAKY," SO THE DEVICE WAS CHECKED WITH THE PATIENT PROGRAMMER AND IT WAS FOUND THE RIGHT DEVICE WAS LOSING BATTERY POWER. A "CALL YOUR DOCTOR" MESSAGE WAS DISPLAYED, AND IT WAS REPORTED THE DEVICE HAD ABOUT 3 MONTHS OF BATTERY LEFT. THE DEVICE HAD NOT BEEN CHECKED FOR A WHILE PREVIOUS TO THE EVENT. IT WAS STATED THE REPORTER WOULD HAVE A REAL PROBLEM ON THEIR HANDS, IF THE BATTERY STOPPED BEFORE IT COULD BE REPLACED. IT WAS REPORTED THE BATTERY ON THE RIGHT SIDE NEEDED REPLACEMENT AND IT WAS WAY TOO SOON. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214005 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1