BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4150998 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18473
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-40, LOT# VA0FBWL, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387S-40, LOT# VA09PRB, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURING REPRESENTATIVE REPORTED THAT LOW IMPEDANCES WERE MEASURED ON (B)(6) 2016. IMPEDANCES WERE MEASURED TO BE 98 OHMS ON ELECTRODE PAIR 10-11. ALL OTHER IMPEDANCES WERE MEASURED TO BE WITHIN NORMAL RANGE. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PROGRAMMED TO C+, 10 AND THE THERAPY IMPEDANCE WAS 753 OHMS ON THE RIGHT SIDE. THERE WERE NO CLINICAL COMPLAINTS REPORTED AND THE ELECTRODES WITH THE SHORT WERE NOT BEING USED FOR PROGRAMMING. THE PATIENT LATER REPORTED THERE WAS A SHORT AND THEY HAD THEIR DEVICE CHECKED TWICE. THE PATIENT WANTED TO KNOW WHY THEY COULD NOT HAVE AN MRI, IF THEY COULD HAVE SURGERY WITHOUT AN MRI, AND WHETHER THEY NEEDED SURGERY TO FIX THE SHORT CIRCUIT. THE PATIENT PLANNED TO FOLLOW UP WITH THEIR HEALTH CARE PROVIDER. THE PATIENT'S INDICATION FOR USE IS PARKINSON'S DUAL AND MOVEMENT DISORDERS. NO CAUSE, TROUBLESHOOTING, ACTIONS/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.

    Description of Event or Problem · 1

    IT WAS REPORTED ON THE DATE OF THE EVENT, AN IMPEDANCE OF 83 OHMS WAS NOTICED ON ELECTRODES 10 AND 11, WHILE OTHER VALUES AND THE CASE VALUES WERE FINE. IT WAS NOTED THE PATIENT'S IMPEDANCES WERE FINE LAST MONTH. THE PATIENT WAS PROGRAMMED ON C+, 10- AND WAS THERAPEUTICALLY DOING FINE. NO SYMPTOMS OR INTERVENTIONS WERE REPORTED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633318 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1