BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2934094 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01099
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Report Date
    January 16, 2013
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387-40, LOT# J0519173V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT# J0519173V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW IMPEDANCES WERE SEEN ON THE PATIENT'S IMPLANTABLE NEUROSTIMULATORS (INS) BUT IT WAS UNCLEAR WHICH INS SYSTEM WAS INVOLVED. THE PATIENT WAS PROGRAMMED WITH ELECTRODE #1 AND 2 WHICH INCLUDED ONE OF THE ELECTRODES (#1) NOTED TO BE INVOLVED WITH THE LOW IMPEDANCE ISSUE. IT WAS NOTED THAT THE PATIENT WAS GETTING THERAPEUTIC RELIEF DESPITE THE LOW IMPEDANCE ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. SEE ALSO MANUFACTURER¿S REPORT # 3004209178-2013-01098 SEE MANUFACTURER'S REPORT #'S 3004209178-2013-01096 AND 3004209178-2013-01097 FOR PRIOR DEVICE IMPEDANCE ISSUES.

    Description of Event or Problem · 1

    FOLLOW UP REPORTED TO THE REPORTERS KNOWLEDGE "THERE WERE NO LEAD FRACTURES." IT WAS NOTED IT WAS UNKNOWN IF THE ISSUE HAD BEEN RESOLVED AND "THE SURGEON WAS NOT CONCERNED." IT WAS ALSO NOTED THERE WAS NO INTERVENTION NEEDED PER THE SURGEON. PATIENT OUTCOME AND STATUS IS UNKNOWN AT THIS TIME BUT IT WAS NOTED THE PATIENT WAS SENT TO THEIR NEUROLOGIST FOR FOLLOW UP. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE. REFER TO MANUFACTURER REPORT # 3004209178-2013-01097 REPORT ON LOW IMPEDANCES PRIOR TO NEW STIMULATOR. REFER TO MANUFACTURER REPORT # 3004209178-2013-01098. PATIENT HAS MULTIPLE DEVICES AND IT IS UNCLEAR WHICH DEVICE PERTAINS TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41365 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1