BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 1843564 · Received September 22, 2010

    Report

    Report Number
    3004209178-2010-07190
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 21, 2010
    Report Date
    August 23, 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 INITIALLY REPORTED THAT A PT HAD WENT TO AN ER WITH A BODY TEMPERATURE OF 104.3. SWELLING AND OOZING WERE ALSO REPORTED. IT WAS LATER REPORTED THAT PT TESTED POSITIVE FOR (B)(6), AND WAS SENT HOME WITH A PERIPHERALLY INSERTED CENTRAL CATHETER LINE WITH VANCOMYCIN AND MEROPENEM. THE PT WAS NOTED AS DOING WELL FOLLOWING THE EXPLANT OF HIS DEVICES, AND WAS RECOVERING NICELY WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# V008495| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN007373V| IMPLANTED: