BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2070169 · Received April 25, 2011

    Report

    Report Number
    3004209178-2011-03087
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    May 6, 2010
    Report Date
    April 11, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN (B)(6) 2010, THAT THE PT EXPERIENCED ISSUES WITH HER INCISION HEALING AND SWELLING AT THE PUMP POCKET SITE. THE INCISION WAS OPENED AND THERE WAS FLUID ACCUMULATION IN THE POCKET AFTER THE PUMP REPLACEMENT PROCEDURE. IT WAS LATER REPORTED THAT THE PHYSICIAN DISCOVERED A BREAK OR TEAR IN THE CATHETER AT THE CONNECTION SITE, THAT REQUIRED THE PT TO UNDERGO A CATHETER REVISION. THE DATE FOR THIS PROCEDURE WAS NOT STATED. THE PT RECOVERED WITHOUT SEQUELA AFTER THE REVISION. THE MEDICATION BEING DELIVERED VIA THE DEVICE WAS LIORESAL 500MCG/ML.

    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 30 YR Hospitalization| R CATHETER: MODEL 8703W, LOT# L53969| EXPLANTED:| IMPLANTED: