BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5096992 · Received September 23, 2015

    Report

    Report Number
    3004209178-2015-18478
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    August 30, 2015
    Report Date
    August 31, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 748295, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# V001242, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 748295, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# V000654, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4)

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT AN ELECTIVE REPLACEMENT INDICATOR (ERI) ERROR CODE WAS DISPLAYED. THE REPORTER WAS SURPRISED THE IMPLANTABLE NEUROSTIMULATOR (INS) NEEDED TO BE REPLACED SINCE IT HAD ONLY BEEN 1.5 YEARS. THE PATIENT HAD SUDDENLY BROKEN OUT IN A SWEAT YESTERDAY. WHEN THE INS WAS CHECKED, THE ERI MESSAGE WAS SEEN. THE PATIENT'S INDICATION FOR USE IS DYSTONIA AND MOVEMENT DISORDERS. 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
    629897 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR