BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3120435 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07901
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HCP QUESTIONED THE CATHETER PLACEMENT. IT WAS UNCLEAR IF THE CATHETER WAS DISLODGED BUT PER THE REPORTER THE HCP BELIEVED IT MIGHT BE ¿KNOCKING INTO SOMETHING". THE HCP WAS LOOKING AT THE CATHETER UNDER FLUORO AND QUESTIONED IF THE RADIOPAQUE DOT WAS THE TIP OF THE CATHETER OR IF THERE WAS MORE CATHETER AFTER THAT. THERE WERE NO PATIENT SYMPTOMS REPORTED. IT WAS LATER REPORTED THAT THE PATIENT HAD A FULL REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222528 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention