BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3010455 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03908
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8731SC LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S CATHETER WAS NOT SEEN IN THE INTRATHECAL SPACE UNDER FLUOROSCOPY OR WITH A MAGNETIC RESONANCE IMAGING (MRI) SCAN. HOWEVER, A LITTLE PIECE OF A CATHETER WAS SEEN CONNECTED TO THE PUMP. IT WAS UNSURE IF THIS CATHETER HAD BEEN CONNECTED TO AN EXISTING NON-MEDTRONIC CATHETER WHEN THE MEDTRONIC PUMP WAS IMPLANTED. IT WAS UNKNOWN IF THE PATIENT WAS GETTING APPROPRIATE THERAPY AS THE PATIENT WAS REPORTED TO BE STABLE AND NO WITHDRAWALS WERE REPORTED. HOWEVER, THE PATIENT WAS SUPPLEMENTED WITH INCREASED ORAL MEDICATION. IT WAS LATER REPORTED THAT THE PHYSICIAN PLANNED TO REVISE THE NON-MEDTRONIC CATHETER WITH A MEDTRONIC CATHETER. IT WAS UNCLEAR WHAT MEDICATION THIS DEVICE SYSTEM DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113672 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC MED REL MEDTRONIC PUERTO RICO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention