BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2962301 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02670
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 18, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4). PRODUCT TYPE: CATHETER: PRODUCT ID 8709SC, SERIAL# N283476010, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A FLIPPED PUMP AND THEN A POCKET REVISION. THE DATE OF THE FLIPPED PUMP DIAGNOSIS WAS UNKNOWN TO THE REPORTER. THE HEALTHCARE PROVIDER (HCP) WAS ABLE TO FLIP THE PUMP BACK MANUALLY WITHOUT SURGICAL REVISION, BUT A POCKET REVISION DID TAKE PLACE ON (B)(6) 2013 WHERE THE HCP MOVED THE PUMP UP IN THE POCKET AREA AND SUTURED IT DOWN FIRMLY. THE PATIENT HAD NO THERAPY CHANGES DUE TO THE EVENT AND REPORTED HAVING GREAT THERAPY. IT WAS REPORTED LATER THAT DAY THAT THE REVISION WENT VERY WELL AND THAT IT WAS FOUND UPON REVISION THAT THE ORIGINAL IMPLANTER OF THE PUMP CREATED TOO LARGE OF A POCKET, SO THE HCP CREATED A NEW SMALLER POCKET. CATHETER WAS VERIFIED TO BE INTACT AND THE HCP RECEIVED GOOD CSF FLOW RETURN. IT WAS LATER REPORTED THAT THE PATIENT DID NOT EVER, NOR WERE THEY CURRENTLY SUFFERING FROM ANY ADVERSE SYMPTOMS RELATED TO PUMP THERAPY, OR THE EVENT. THERE WERE NO CHANGES IN DOSE OR CONCENTRATION MADE, AND NO PRODUCT EXPLANATION WAS NECESSARY AS THE EXISTING PUMP MOVED TO NEW POCKET. THE DRUG BEING DELIVERED VIA THE PUMP WAS MORPHINE. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65008 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention