BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3031432 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04503
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT ONE POINT AND THEY WERE TO HAVE A MAGNETIC RESONANCE IMAGING (MRI) STUDY. THE REASON FOR THE MRI WAS NOT CONFIRMED; HOWEVER, IT WAS NOTED THEY WANTED TO SEE THE TIP OF THE CATHETER. THE DRUG IN THE PUMP WAS NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT "DOES" NOT HAVE AN INFECTION AT THE CATHETER OR PUMP POCKET SITE. IT REMAINED UNCLEAR IF THE PATIENT EVER HAD AN INFECTION. THE MEDICATION USED WITHIN THE SYSTEM WAS DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134445 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other "SEE H10...."