BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3770658 · Received April 24, 2014

    Report

    Report Number
    3004209178-2014-08076
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    April 3, 2014
    Manufacturer
    MEDTRONIC 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

    PRODUCT ID 8780, SERIAL# (B)(6), IMPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD SIGNIFICANT LEFT LEG WEAKNESS IN THE RECOVERY ROOM. THE REPORTER FURTHER STATED, THE PATIENT HAD LEFT LEG WEAKNESS AND WAS OTHERWISE AT BASELINE BESIDES POST OPERATION PAIN. IT WAS NOTED THAT THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. THE PUMP CONTAINED MORPHINE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN MRI AND CT SCAN CONFIRMED THE CATHETER WAS INTRA MEDULLARY. THE REPORTER STATED, THE PATIENT¿S HEALTHCARE PROFESSIONAL RECOMMENDED EXPLANT OF THE CATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THE CATHETER WAS EXPLANTED ON 2014 (B)(6). IT WAS NOTED THERE WAS NO DEVICE ISSUE. IT WAS FURTHER NOTED THE PATIENT WAS NOT RECEIVING THERAPY. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249301 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention