BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3092910 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07308
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8781, LOT# 0205940472. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS RETENTION OF A "CONSIDERABLE" AMOUNT OF SEROUS EFFUSION BETWEEN "40 AND 50 ML" WAS OBSERVED IN A SUBCUTANEOUS AREA AROUND THE PUMP. IT WAS REPORTED "CONSIDERING THE AMOUNT, THE RETAINED FLUID MIGHT BE FROM REGURGITATION OF THE CEREBROSPINAL FLUID, AND NOT BACLOFEN." THE PATIENT MIGHT HAVE SELECTED ONE OF THE FOLLOWING OPTIONS "REINFORCING PURSE-STRING SUTURE BY SURGERY, IF ITB TO CONTINUE" AND "REMOVAL OF PUMP SYSTEM, IF ITB TO DISCONTINUE." IT WAS REPORTED THAT "IN EITHER CASE, THE PATIENT WILL BE HOSPITALIZED AND RECEIVE SURGERY." THE PUMP WAS LATER FILLED WITH SALINE. IT WAS LATER REPORTED THAT A CATHETER CONTRAST STUDY WAS PERFORMED ON 2/18/2013 AND THAT "THERE WAS NO PROBLEM WITH THE CATHETER."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS EXPLANTED ON (B)(6) 2013. THE PATIENT OUTCOME WAS REPORTED AS 'RECOVERING.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195318 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention