BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3233827 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11969
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    July 12, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC LOT# SERIAL# N247564012 IMPLANTED: 2010-05-24 EXPLANTED: PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE HAD TWO PUMP POCKET FILLS SOMETIME IN 2011. THE PATIENT EXPERIENCED BURNING FROM THE PUMP AREA DOWN TO HER LEGS WHICH LAST FOR APPROXIMATELY A DAY AS A RESULT OF THE POCKET FILLS. IT WAS NOT PROVIDED WHAT MEDICATION THE DEVICE SYSTEM DELIVERED AT THE TIME OF THE EVENT. (PLEASE NOTE THAT A BURNING SENSATION POST REFILL HAD BEEN PREVIOUSLY REPORTED IN MANUFACTURER REPORT # 3004209178-2010-05470 UNCLEAR DATE OF WHEN THAT OCCURRED AS THERE WAS NO REPORT OF POCKET FILL AT THAT TIME). ADDITIONAL INFORMATION 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
    334478 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Other