BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3010189 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03897
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 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 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT # V119981, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # V017959, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT INVALID IMPEDANCE READINGS OF "???" WERE SEEN ON CONTACTS 4<(>&<)>6 AS WELL AS 4<(>&<)>7 AT THE SAME TIME AS THE PREVIOUSLY REPORTED HIGH IMPEDANCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-OPERATIVE IMPEDANCE TESTING OF THE IMPLANTABLE NEUROSTIMULATOR (INS) SHOWED THAT THERE WERE HIGH VALUES ON SOME CONTACTS. THE BIPOLAR IMPEDANCES WERE TESTED AT 1.5V AND THEY WERE "HIGH." IT WAS REPORTED THAT NO ACTION WAS NEEDED. THE INS WAS REPLACED AS PLANNED AND THE IMPEDANCES POST-OPERATION WERE "NORMAL." IT WAS STATED THAT THE PATIENT WAS ALIVE WITH NO ADVERSE EVENT OR INJURY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114104 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention