BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3745743 · Received April 11, 2014

    Report

    Report Number
    3004209178-2014-07074
    Event Type
    Injury
    Date Received
    April 11, 2014
    Report Date
    March 24, 2014
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3387-40, LOT # V002359, 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 3387-40, LOT # V002359, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN (B)(6) 2010 WHEN THEY HAD TO GET THE IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED IT WAS ¿KNOCKED OUT AND DIDN¿T WORK.¿ IT WAS NOTED IT STILL HAD SHOWED THEY HAD TIME TO GO AND THE PATIENT WAS SYMPTOMATIC. IT WAS STATED IT WAS ¿NOT ALWAYS COMPLETELY ACCURATE BASED ON WHAT THE VOLTAGE SAID.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD RECEIVED ASSISTANCE AND THEIR CONCERNS WERE RESOLVED OVER THE PHONE AND EMAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223983 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention