BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3483626 · Received November 22, 2013

    Report

    Report Number
    3004209178-2013-21299
    Event Type
    Injury
    Date Received
    November 22, 2013
    Report Date
    November 4, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3389S-40, LOT# V006364, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-05, LOT# N072457, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3387S-40, LOT# V006969, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3550-05, LOT# N072457, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3550-05, LOT# N072460, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3387S-40, LOT# V006341, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THE PATIENT WAS IMPLANTED ONLY 7 YEARS AGO. IT WAS NOTED THAT THE PATIENT WAS COMING IN FOR A REPLACEMENT DUE TO BREAKTHROUGH SYMPTOMS. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY MEASUREMENT WAS 3.0 VOLTS. IT WAS NOTED THAT ELECTRODE IMPEDANCES WERE GREATER THAN 4000 ON SOME CONTACTS BUT THE REPORTER STATED THAT THE CURRENT WAS GREATER THAN 15 A ON THE SAME CONTACTS SO THE REPORTER BELIEVES THAT THE SYSTEM WAS FINE IMPEDANCE WISE. IT WAS NOTED THAT THE PATIENT WAS EXTREMELY SENSITIVE TO IMPEDANCE CHECKS, SO THEY HAD TO RUN THE MEASUREMENTS AT 0.7 VOLTS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO FURTHER DIAGNOSTIC TEST WERE PERFORMED. IT WAS NOTED THAT NO MALFUNCTIONS WERE SEEN OR CAUSE OF EVENT DETERMINED. IT WAS NOTED THAT THE DATE OF REPLACEMENT WAS ¿TO BE DETERMINED.¿ IT WAS NOTED THAT THE PATIENT WAS DOING WELL AND THAT THEY ADJUSTED HIS THERAPY AND HE WAS RECEIVING EFFECTIVE THERAPY. IT WAS FURTHER NOTED THAT THE MANUFACTURING REPRESENTATIVE DID NOT REPORT THAT THE PATIENT HAD HIGH IMPEDANCES. IT WAS NOTED THAT ALL IMPEDANCES WERE NORMAL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT ENDED UP HAVING HIS DEVICE REPLACED ON (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608402 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention