BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2081300 · Received April 21, 2011

    Report

    Report Number
    3004209178-2011-02971
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 31, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE NEUROSTIMULATOR WAS REPLACED, THE PT EXPERIENCED A LACK OF THERAPY, BUT DID NOT WANT TO INCREASE THE STIMULATION. INTERROGATION OF THE DEVICE SHOWED HIGH IMPEDANCES OF >4000 OHMS ON ELECTRODE PAIR #4 & #6 AT 3 VOLTS, 240 PW. ALL OTHER IMPEDANCES IN THE RANGE OF 443 TO 3219 OHMS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR EXTENSION: MODEL 7482, LOT# NHU079309V| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU079310V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# J0451702V| IMPLANTED:| LEAD: MODEL 3387, LOT# J0451702V| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED: