BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2161993 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-05275
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE NEUROSTIMULATOR HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR WAS EXPLANTED DUE TO INFECTION. THERE WAS NO INFORMATION PROVIDED REGARDING THE INFECTION-CAUSING ORGANISM. THE PATIENT REQUESTED THE IMPLANTATION OF A NEW DEVICE. THE PATIENT'S PHYSICIAN REFUSED TO IMPLANT A NEW DEVICE AS IT WAS THOUGHT THAT THE PATIENT WAS "NOT FIT FOR IMPLANTATION." NO FURTHER PATIENT SYMPTOMS OR OUTCOME WERE PROVIDED. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 UNK Required Intervention