BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3854333 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10284
    Event Type
    Injury
    Date Received
    June 6, 2014
    Report Date
    May 16, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, LOT# N186302012, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED PATIENT WAS DISPLAYING SIGNS OF INCREASED SPASTICITY. THE OFFICE SAW THE PATIENT AND IMMEDIATELY FELT THAT IT WAS NECESSARY FOR THE PATIENT TO BE SCHEDULED FOR A REVISION DUE TO THE WAY THE PUMP SITE APPEARED. THE SITE OF THE PUMP WAS RED, HOT AND THERE WERE SIGNS OF POTENTIAL EROSION. IT WAS NOTED THAT THE SYSTEM WAS REMOVED ON (B)(6) 2014. A CULTURE WAS TAKEN AT THE TIME OF EXPLANT FROM THE PUMP POCKET AND THE CULTURE CAME BACK COMPLETELY NEGATIVE. THE PATIENT RECOVERED WELL AND A NEW CATHETER WAS IMPLANTED ON (B)(6) 2014. THE PATIENT OUTCOME WAS NOTED AS RECEIVING EFFECTIVE THERAPY. THE PUMP WAS USED TO DELIVER BACLOFEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED POCKET. PER THE REPORTER, THE CATHETER WAS BROKEN AT THE SPINAL SEGMENT PRIOR TO THE CASE. ON (B)(6) 2014, THE OLD SYSTEM WAS REMOVED AND A NEW SYSTEM WAS PLACED. THE MEDICATION DELIVERED BY THE DEVICE SYSTEM WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332887 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention