BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 3901621 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12250
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 9, 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: PRODUCT ID 3387-40, LOT# J0316168V, PRODUCT TYPE LEAD, PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD, PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN. PRODUCT TYPE LEAD. PRODUCT ID 3387S-40, LOT# V151139, PRODUCT TYPE LEAD. PRODUCT ID 748251, SERIAL# (B)(4), PRODUCT TYPE EXTENSION, PRODUCT ID 748251, SERIAL# (B)(4), PRODUCT TYPE EXTENSION. PRODUCT ID 7436, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD, PRODUCT ID 3387S-40, LOT# V151139, PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387-40, LOT# J0316168V, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V151139, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), PRODUCT TYPE EXTENSION (X2); PRODUCT ID 7436, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V151139, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED IT WAS DETERMINED THERE WAS A PROBLEM WITH THE IMPEDANCES. IT WAS UNKNOWN IF THE PATIENT HAD ANY SYMPTOMS OR DEVICE RELATED ISSUES. THE CAUSE OF THE IMPEDANCE ISSUES WAS NOT YET DETERMINED. IT WAS UNKNOWN IF IT WAS DEVICE RELATED. IT WAS UNKNOWN IF ANY LEAD FRACTURES WERE NOTED. NO TROUBLESHOOTING, INTERVENTION OR OTHER ACTIONS HAD BEEN TAKEN TO RESOLVE THE EVENT YET. IT WAS UNKNOWN HOW THE PATIENT WAS DOING OR IF THEY WERE RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE IMPEDANCES OF GREATER THAN 4000 OHMS. PATIENT HAD TWO THALAMIC LEADS IN A KINETRA AND HAD 2 GLOBUS PALLIDUS LEADS THAT WERE NOT CONNECTED TO AN IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT HAD TOURETTE¿S. LEFT WAS PROGRAMMED AT 3+,1-; 2.3V; 180PW; 188 AND IMPEDANCES READ 0/C >4000, 1/C >4000, 2/C ???, 3/C 1395, 0/1 >4000, 0/2 >4000, 0/3 >4000, ½ 1395, 1/3 >4000, AND 2/3 1395. RIGHT WAS PROGRAMMED AT 7+, 5-; 2.5V; 210PW; 185 AND IMPEDANCES READ 4/C 1395, 5/C 1395, 6/C 690, 7/C 690, 4/5 1395, 4/6 1395, 4/7 1395, 5/6 ???, 5/7 1395 AND 6/7 690. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379353 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1