BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3203542 · Received July 3, 2013

    Report

    Report Number
    6000030-2013-00067
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    July 16, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT# J0056643R, IMPLANTED: 2001-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED. PATIENT REPORTED THERE WAS NO CHANGE WHEN HE GOT THE FIRST IMPLANT IN 2001. STATED HE WENT INTO THE SITUATION FOR THE PROBLEMS TO BE RESOLVED THEY HAVE NEVER BEEN RESOLVED. PATIENT REPORTED AT A PARTICULAR POINT IN THE SITUATION A SUGGESTION WAS MADE ¿THERE¿S A PROBLEM WITH THE PUMP¿ THEREFORE THE PUMP WAS REPLACED. ABOUT TWO MONTH AFTER THE REPORTED EVENT, A COMPANY REPRESENTATIVE REPORTED THE PATIENT HAD INDICATED THE PUMP NEVER WORKED HOW IT WAS PROMISED ¿ IT NEVER ELIMINATED THE EXTREME JERKING OF HIS LIMBS, CAUSED BY MULTIPLE SCLEROSIS. PATIENT SAID HE HAD A SERIES OF ISSUES WITH THE PUMP, THE LEADS AND THE DOSES OF MEDICATION THAT HE BLAMES FOR CAUSING SPASMS AND TWITCHES. HE DESCRIBED IT AS BEEN LIKE A PUPPET ¿ ¿SOMEONE IS DANGLING A STRING CONNECTED TO YOUR LIMBS AND YOU CAN'T CONTROL IT¿. SYSTEM USED TO DELIVER BACLOFEN. IF ADDITIONAL INFORMATION IS RECEIVED A REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304709 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627-18

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention