BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4192715 · Received October 22, 2014

    Report

    Report Number
    3004209178-2014-20164
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    September 26, 2014
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CATHETER REPLACEMENT OR REVISION ON 2014 (B)(6) BECAUSE, HE WAS EXPERIENCING NUMBNESS. THE PATIENT HAD BEEN COMPLAINING OF THIS NUMBNESS FOR 2 YEARS. THIS NUMBNESS OCCURRED FROM THE PATIENT¿S CHEST ALL THE WAY DOWN HIS LEG. IT WAS WORSE WHILE HE WAS SITTING IN A CAR, AS HE WOULD GO COMPLETELY NUMB AT THIS TIME. A ¿SCAN¿ SHOWED THAT THE PATIENT¿S CATHETER HAD MOVED OFF TO THE LEFT SIDE. SINCE THE CATHETER REPLACEMENT, THE PATIENT¿S NUMBNESS HAD RESOLVED COMPLETELY. THE DEVICE SYSTEM WAS USED TO DELIVER BUPIVACAINE AND DILAUDID. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672980 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention