BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4122961 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17836
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    April 9, 2014
    Report Date
    September 5, 2014
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3387S-40, LOT# V838541, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-60, SERIAL# (B)(4), PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3387S-40, LOT# V838541, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# V750613, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NOT A 50% OR GREATER SYMPTOM REDUCTION. THE COMPONENT INVOLVED IN THE EVENT WAS THE PROGRAMMER. REPROGRAMMING WAS DONE AND STIMULATION WAS REDUCED. THE CAUSE OF THE EVENT WAS DETERMINED AND IT WAS NOT DEVICE RELATED. THERE WAS OVERSTIMULATION WITH 7.2UA. THE PATIENT HAD RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT NEEDED TO PUT THEIR PROGRAM AT THE HIGHEST LEVEL TO EAT. THE PATIENT COULD TELL IT WAS ON BECAUSE IT ¿ELECTROCUTED¿ THEM. THE PATIENT COULD FEEL IT GO THROUGH THEIR FACE AND THEIR FACE WOULD TWITCH DOWN TO THEIR HANDS. IT WAS NOTED THE PROGRAM NEEDED TO BE THAT HIGH IN ORDER FOR THERAPY TO WORK SO THE PATIENT CAN EAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600830 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Other