BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2767416 · Received October 1, 2012

    Report

    Report Number
    3004209178-2012-08745
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Report Date
    September 13, 2012
    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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3387S-40, LOT# V012374, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS LOW IMPEDANCE; LESS THAN 50 OHMS WITH CONTACTS 0 AND 1 IN BIPOLAR MODE TOGETHER. THE PATIENT EXPERIENCED OVERSTIMULATION WITH NO INJURY. REPROGRAMMING WAS PERFORMED AROUND CONTACTS 0 AND 1, THERAPY WAS OBTAINED WITH "GREAT TREMOR RELIEF" AND "NO SHOCKING SYMPTOMS" WERE OBSERVED. A FEW DAYS LATER THE PATIENT RETURNED WITH SHOCKING. THE SHOCKING WAS DESCRIBED EVEN WITH THE DEVICE OFF. IT WAS REPORTED NO INTERVENTIONS WERE CURRENTLY PLANNED. THE PATIENT HAD ASKED IF HIS "DEVICE CAN BE REPLACED TO TRY TO ELIMINATE THE PROBLEM." THE PATIENT WAS SCHEDULED FOR AN APPOINTMENT ON (B)(6) 2012 WITH MANUFACTURER'S REPRESENTATIVE. OUTCOME HAD NOT BEEN DETERMINED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE IMPEDANCE ISSUE WHICH WAS INDICATIVE OF A SHORT HAD SINCE RESOLVED ITSELF. UPON INTERROGATION OF THE PATIENT'S DEVICE AND IMPEDANCE TESTING THE VALUES WERE ALL WITHIN NORMAL RANGE AND THE ISSUE PREVIOUSLY SEEN WAS NO LONGER PRESENT. THE PATIENT WAS ABLE TO BE REPROGRAMMED TO THE SETTING AT WHICH HE HAD BEEN PROGRAMMED FOR SOME TIME PRIOR. UPON MAKING THE CHANGE THE PATIENT EXPERIENCED BETTER TREMOR CONTROL. THE PATIENT LEFT HIS CLINIC WITH THE UNDERSTANDING HE WAS TO MONITOR HIS TREMOR AND ANY SHOCKING THAT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1