BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL II

    MDR report key: 2421390 · Received January 19, 2012

    Report

    Report Number
    3004209178-2012-00353
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Report Date
    December 29, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3387S-40, LOT #V013793, IMPLANTED: (B)(6) 2007, EXPLANTED: NA. EXTENSION: MODEL 748251, SERIAL #(B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: NA. NEUROSTIMULATOR: MODEL 7426, SERIAL #(B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: NA. LEAD: MODEL 3387S-40, LOT #V014497, IMPLANTED: (B)(6) 2007, EXPLANTED: NA. EXTENSION: MODEL 748251, SERIAL #(B)(4) IMPLANTED: (B)(6) 2007 EXPLANTED: NA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT SINCE THE PATIENT WAS RECEIVING BENEFICIAL THERAPY WITH THE NOTED SHORT CIRCUIT, THE HEALTHCARE PROFESSIONAL WAS GOING TO WAIT UNTIL THEY CHANGE OUT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY BEFORE REPLACING THE LEAD. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW IMPEDANCES (<(><<)>50 OHMS) WERE MEASURED THE ELECTRODE COMBINATION OF #1 AND 2 ON THE PATIENT'S IMPLANTED NEUROSTIMULATOR SYSTEM. IT WAS NOTED THAT THE PATIENT WAS PROGRAMMED WITH THAT COMBINATION AS IT WAS THE ONLY TWO THAT CONTROLLED SYMPTOMS. THIS ELECTRODE COMBINATION WAS ALSO REPORTED TO BE WITHIN THE SUBTHALAMIC NUCLEI REGION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL II STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1