BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2821703 · Received November 6, 2012

    Report

    Report Number
    6000030-2012-00190
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    October 10, 2012
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT ID: 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2003 (B)(6), EXPLANTED: 2011 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8578 LOT# SERIAL# (B)(4), PRODUCT TYPE ACCESSORY (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2003-(B)(6), EXPLANTED: 2011-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PUMP IMPLANT ON (B)(6), 2003 THE PUMP WAS "PUT IN INCORRECTLY". IT WAS ALSO REPORTED THAT THE CATHETER HAD KINKED AND "WASN'T DRIPPING MEDICATION PROPERLY". THE PATIENT WENT THROUGH WITHDRAWAL PRIOR TO HAVING THE PUMP AND CATHETER REPLACED BUT THE REPORTER COULD NOT RECALL WHEN THIS OCCURRED. THE REPORTER COULD NOT RECALL THE SYMPTOMS THE PATIENT EXPERIENCED. THE HEALTHCARE PROVIDER (HCP) PERFORMED TESTING ON THE PUMP BUT THE REPORTER COULD NOT RECALL WHAT TYPES OF TESTS WERE DONE. THE PUMP AND CATHETER WERE BOTH REPLACED. IT WAS NOT CLEAR WHAT MEDICATIONS THIS DEVICE SYSTEM DELIVERED; HOWEVER, MEDICATIONS LISTED INCLUDED CLONIDINE, BUPIVACAINE, BACLOFEN AND DILAUDID (HYDROMORPHONE). ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE PATIENT'S FORMER MANAGING PHYSICIAN HAS RETIRED AND THE REPORTER WAS UNSURE WHAT PHYSICIAN TOOK OVER THE PATIENT'S CARE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention