BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3863912 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01472
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 7, 2014
    Report Date
    February 1, 2017
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3389-28, LOT # 0206903490, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3389-28, LOT # 0206722956, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3708695, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708695, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3389-28, LOT # 0206903490, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3389-28, LOT # 0206722956, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE EVENT WAS NOT RELATED TO ANYTHING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT BUMPED THEIR HEAD HARD AT THEIR LEFT LEAD LOCATION AND HAD A SEIZURE 30 MINUTES AFTER. APPROXIMATELY ONE MONTH LATER THE PATIENT HAD A SEIZURE AND FELL OF THEIR BIKE. BOTH TIMES AN AMBULANCE CAME ON LOCATION BUT NO FURTHER ACTION WAS NEEDED. THE EVENT WAS CONSIDERED UNRESOLVED WITH NO FURTHER ACTION PLANNED. IT WAS UNKNOWN IF THE EVENT WAS RELATED TO THE PROGRAMMING, STIMULATION, OR MEDICATION. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341379 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC EUROPE SARL 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR