BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4123273 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17840
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37092, LOT# 214180001, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 748295, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V055961, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V045101, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. TWO TO THREE DAYS PRIOR TO REPORT THE SHAKING HAD RETURNED AND THEY WENT TO THE HOSPITAL AND IT WAS DETERMINED THAT ONE OF HIS PROGRAMS WAS SET TO 1V AND THAT MOST LIKELY CAUSED THE CHANGE IN SYMPTOMS. THE PROGRAM WAS ADJUSTED. THE PATIENT CURRENTLY RECHARGED EVERY 3 DAYS. 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
    602481 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR