BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3973825 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13854
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8590-1, LOT# N342954, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED A HEMATOMA AT THE POCKET SITE. THE PHYSICIAN WAS GOING TO EXPLORE AND CLEAN OUT THE SITE, LEAVING THE PUMP IMPLANTED. THERE WAS A SEROMA AT THE DEVICE POCKET. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ¿ALIVE- NO INJURY.¿ THERE WAS NO ALLEGED PRODUCT ISSUE. THE SYSTEM WAS BEING USED TO DELIVER FENTANYL.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT A REVISION SURGERY OCCURRED ON (B)(6) 2014, AT WHICH TIME THE HEALTHCARE PROVIDER (HCP) CLEANED UP THE HEMATOMA. SINCE THEN, THE PATIENT HAD BEEN RECEIVING EFFECTIVE THERAPY. THE HEMATOMA WAS INDICATED TO BE SURGERY-RELATED, AND NOT RELATED TO THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451192 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention