BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4804800 · Received May 29, 2015

    Report

    Report Number
    3004209178-2015-09900
    Event Type
    Injury
    Date Received
    May 29, 2015
    Report Date
    May 7, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID: 3389S-40, LOT# V012773, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V012773, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 37092, LOT# 328720001, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY PRODUCT ID: 37651, LOT# SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 64002, LOT# N340417, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER. PRODUCT ID: 748251, SERIAL# (B)(4) IMPLANTED:(B)(4) 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 THAT THE PATIENT WAS FEELING STIMULATION ON THE NIGHT PRIOR TO THE DATE OF THIS REPORT BUT THE PATIENT¿S WIFE WAS WORRIED THAT THE PATIENT¿S BATTERY HAD GONE DEAD SINCE HE COULD NO LONGER MOVE HIS LEGS LIKE BEFORE AND HE WAS NOT FEELING GOOD. THERE WERE NO FALLS OR ACCIDENTS. THE LAST SUCCESSFUL RECHARGING SESSION WAS A FEW DAYS PRIOR TO THE DATE OF THIS REPORT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS UNKNOWN IF THE RECHARGING FREQUENCY HAD MATCHED THE PATIENT¿S SETTINGS. IT WAS UNKNOWN IF PATIENT WAS TRAINED AND ABLE TO DEMONSTRATE EFFECTIVE RECHARGING. THE PATIENT WAS IN CONTINUOUS MODE. THE CAUSE OF THE EVENT WAS DETERMINED AND WAS DEVICE RELATED. THE PATIENT HAD UNDERGONE A REPLACEMENT. THE RECHARGEABLE DEVICE WAS OVERSTIMULATED EVEN THOUGH SETTINGS WERE THE SAME. IT WAS UNKNOWN IF THE PATIENT WAS RECHARGING NORMALLY AND IF THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. THE PATIENT HAD BEEN EVALUATED BY NEUROSURGERY AND WAS REPROGRAMMED ON (B)(4) 2015. PATIENT STATUS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348466 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention