BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2063774 · Received April 15, 2011

    Report

    Report Number
    3004209178-2011-02858
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    September 1, 2010
    Report Date
    April 1, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN (B)(6) 2010, THE PUMP WAS FILLED IN THE HCP OFFICE WITH THE INCORRECT MEDICATION. AS A RESULT, THE PT WAS HOSPITALIZED IN THE INTENSIVE CARE UNIT IN ORDER TO RECOVER. THE PT DID NOT KNOW WHAT MEDICATION WAS IN HER PUMP. THE PT WAS ATTEMPTING TO ESTABLISH CARE WITH ANOTHER PUMP PHYSICIAN. 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 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L EXPLANTED:| CATHETER: MODEL 8709. LOT# J0056645R| IMPLANTED: