BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3811381 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-08969
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COBNCOMITANT PRODUCT: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) OF 2013, PATIENT HAD SURGERY AND THEY ACCIDENTALLY CUT THE CATHETER. THE PATIENT HAD 7 BACK SURGERIES AND ONLY ONE OF THOSE SURGERIES PATIENT HAD AFTER THE PUMP WAS IMPLANTED. IT WAS NOTED THAT THE PATIENT HAD X-RAYS, MRI¿S AND MYELOGRAMS. IT WAS NOTED THAT THE PATIENT WAS OUT FOR 7 ½ HOURS FOR THE SURGERY TO FIX THE CATHETER ISSUE AND FINISH THE SURGERY. IT WAS NOTED THAT THE PUMP HELPS THE PATIENT. THE PUMP SYSTEM WAS DELIVERING BUPIVACAINE, BACLOFEN AND DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291274 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR