BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3093268 · Received May 5, 2013

    Report

    Report Number
    3004209178-2013-07323
    Event Type
    Injury
    Date Received
    May 5, 2013
    Report Date
    April 5, 2013
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8703W LOT# L45809, IMPLANTED: 1998 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PUMP WAS IMPLANTED IT WAS IMPLANTED UPSIDE DOWN. THE PATIENT WENT TO GET A REFILL AND THEY COULDN'T FIND THE PORT. X-RAYS REVEALED IT WAS TURNED UPSIDE DOWN. EMERGENCY SURGERY WAS PERFORMED TO "TURN IT BACK UP". THE PATIENT INDICATED THAT HE ALSO TAKES BREAKTHROUGH MEDICATION AND HAS HAD DIFFICULTY IN GETTING THE PRESCRIPTIONS FILLED. THE HCP WAS NO LONGER GOING TO BE MANAGING PUMP PATIENTS SO THE PATIENT WAS IN THE PROCESS OF TRYING TO SECURE A NEW PHYSICIAN AS HIS LAST REFILL WAS ON (B)(6) 2013 AND HIS PUMP IS REFILLED ABOUT EVERY 60 DAYS. IT WAS ALSO NOTED THAT THE PATIENT HAD FALLEN 28 FEET IN 1992 PRIOR TO THE PUMP IMPLANT, HAD A 3 LEVEL FUSION AND HAD HIS ARM PUT BACK TOGETHER. BONES FROM HIS HIPS WERE USED AND HE ENDED UP WITH AN INFECTION AND HE WAS "ABOUT A GONER". SINCE THAT TIME, THE PATIENT HAS HAD ABOUT 16 SURGERIES. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195833 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention