BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3213400 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11494
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    February 1, 2013
    Report Date
    June 17, 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
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER, PRODUCT ID: 8590-1, LOT# N171755, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT, SIX MONTHS AFTER IMPLANT, THE PUMP STARTED TO FAIL. THE PATIENT HAD A RETURN OF PAIN. THE PATIENT HAD A HOLE IN HIS CATHETER AND THE CATHETER MIGRATED. THE CATHETER WAS REPLACED AND REPOSITIONED AND THE PUMP WAS LEFT IN PLACE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A CATHETER BREAK OCCURRED AND WAS THE CAUSE OF THE EVENT, NEAR THE ANCHOR POINT. THE RESULT OF A CATHETER DYE STUDY WAS ¿LEAKAGE OF DYE¿ HOWEVER THE TIMEFRAME OF THE STUDY WAS NOT PROVIDED. THE SYMPTOM REPORTED WAS ¿LACK OF PAIN CONTROL¿. THE PATIENT RECOVERED WITH NO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD TO HAVE THEIR CATHETER REPLACED BECAUSE ¿THE OTHER ONE WAS LEAKING¿. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313615 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention