BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4152768 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18553
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 17, 2014
    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 MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V014246, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 64002, LOT# N318565, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER; PRODUCT ID 3387S-40, LOT# V014246, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A POWER ON RESET (POR) CONDITION. IT WAS SEEN THE DAY PRIOR TO REPORT BUT THEY WERE ABLE TO PRESS THE GREEN BUTTON AND GOT THEIR NORMAL RECHARGING SCREEN WITH ALL COUPLING BARS FULL. THE PATIENT RECHARGED EVERY DAY AND THEY HAVE NEVER HAD A PATIENT PROGRAMMER. NO PATIENT SYMPTOMS WERE REPORTED. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630714 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR