BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 1892265 · Received November 2, 2010

    Report

    Report Number
    3004209178-2010-08742
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 7, 2010
    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
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WENT TO THE HOSPITAL (B)(6) 2010. THE DOCTOR FOUND THAT THE IMPEDANCES BETWEEN BOTH LEAD POINTS AND IPG WERE HIGHER THAN 4,000 OHMS. THE DOCTOR CHANGED THE PARAMETERS AND THE RESULT WAS THE SAME. SO THE DOCTOR THINKS HIGH DEGREE OF SUSPICION OF A LINK IN THE LOOP CIRCUIT. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 Hospitalization EXTENSION: MODEL 7482, LOT # NHU211242V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3389S-40, LOT# V386123| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT # NHU211245V| LEAD: MODEL 3389S-40, LOT# V357495| EXPLANTED: