BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3980242 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13957
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 14, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, LOT# J11032R51, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S HEALTH CARE PROVIDER (HCP) RETIRED A ¿COUPLE OF YEARS AGO¿ AND DIDN¿T HAVE ANYONE TO TAKE OVER AND AS A RESULT THE PUMP WENT EMPTY AND THE PATIENT HAD THE PUMP SHUT OFF. THE PATIENT DID FIND ANOTHER HCP WHO PUT PAIN PUMPS IN HAD ¿HAD ANOTHER INSTALLED¿. THE TYPE OF MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM AT THE TIME OF THE EVENT WAS NOT PROVIDED; HOWEVER, HYDROMORPHONE WAS LISTED AS AN OLD MEDICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456915 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention