BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4090594 · Received September 15, 2014

    Report

    Report Number
    3004209178-2014-17060
    Event Type
    Injury
    Date Received
    September 15, 2014
    Report Date
    August 18, 2014
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# L69145, IMPLANTED: (B)(6) 1999, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP ¿FAILED¿ AND BECAME INFECTED AND HAD TO BE ¿IMMEDIATELY REMOVED WITH EMERGENCY SURGERY¿. THE PATIENT EXPERIENCED A LOT OF PAIN (ALSO REPORTED AS ¿PAINFUL AROUND THE PUMP SITE¿) AND DISCOMFORT, AND "RISK TO LIFE BY HAVING THE PUMP AND SPINAL CATHETER REMOVED TOGETHER IN A FIVE HOUR SURGERY". IT TOOK THE PATIENT 32 DAYS TO RECOVER ENOUGH FROM THE SURGERY TO BE RELEASED FROM THE CONVALESCENT HOME; THE PATIENT CONTINUED TO RECUPERATE AT HOME UNDER THE 24 HOUR, 7 DAYS A WEEK CARE BY THEIR FAMILY. THE PATIENT WAS STILL ENDURING WITHDRAWALS AND ADJUSTMENTS OF MEDICATION IN HEALING FROM THE EVENT. THE PUMP WAS FIRST BEING USED TO DELIVER DILAUDID AND THEN MORPHINE AT THE TIME OF EXPLANT. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570391 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Life Threatening| R