BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 1800601 · Received August 12, 2010

    Report

    Report Number
    3004209178-2010-06063
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 15, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    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 A PT'S FULL IMPLANTED SYSTEM WAS REMOVED DUE TO AN INFECTION THAT WAS LOCATED OVER ONE OF THE LEADS, ON THE LEFT SIDE OF HER HEAD. IT IS SUSPECTED THAT THE INFECTION MAY HAVE BEEN CAUSED BY A TOOTH ABSCESS. BECAUSE THE LEADS WERE FOUND CROSSED OVER EACH OTHER, BOTH WERE REMOVED ALONG WITH THE EXTENSIONS AND BATTERY. TREATMENT FOR THE INFECTION AND THE PT'S POST-PROCEDURE OUTCOME, WAS NOT REPORTED. IT WAS NOTED THAT THE PT WILL BE REFERRED BACK FOR A LEAD PLACEMENT IN A FEW MONTHS. ADDITIONAL 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 69 YR Required Intervention EXPLANTED:| LEAD: MODEL 3387S, LOT# V042082| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387S, LOT# V042343| EXTENSION: MODEL 7482A, LOT# NHU167139V| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A, LOT# NHU167138V