BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3197509 · Received June 28, 2013

    Report

    Report Number
    3004209178-2013-11049
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2381-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP REVEALED NO ANOMALY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER: PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER: PRODUCT ID 8590-1, LOT# N060034, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: ACCESSORY: PRODUCT ID 8591-38, LOT# A89145, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PLANNED PUMP REPLACEMENT FOR NORMAL BATTERY DEPLETION, THE HEALTH CARE PROVIDER (HCP) USED FLUORO TO CHECK ¿PLACEMENT AND WHERE EXITED THE SPINE¿. THE HCP WAS ABLE TO IDENTIFY THE CATHETER IN THE INTRATHECAL SPACE BUT NOT WHERE IT EXITED THE SPINE. UPON OPENING THE SPINAL INCISION, THE CATHETER WAS FOUND TO BE DISCONNECTED FROM THE PUMP SEGMENT. IT WAS REPORTED THE CATHETER WAS DISCONNECTED AT THE CATHETER TIP AND THE CONNECTOR PIN. THE HCP DECIDED TO REMOVE THE CATHETER. IT WAS REPORTED THERE WAS A PIECE OF SPINAL SEGMENT LEFT IN THE INTRATHECAL SPACE. THE ENTIRE DEVICE SYSTEM WAS REPLACED AND THE REMOVED CATHETER AND PUMP WERE DISCARDED. IT WAS REPORTED THE PATIENT HAD EXPERIENCED LESS THAN FIFTY PERCENT THERAPY RELIEF AND REPORTED CHRONIC PAIN EVEN WITH THE PUMP. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296825 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Other