BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3002514 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03662
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 12, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO ABNORMALITIES WERE FOUND BY THE PHYSICIAN DURING A DYE STUDY, WHICH WAS PERFORMED ON AN UNKNOWN DATE. THE PATIENT HAD REPORTED SOME INCREASED PAIN, AND REQUESTED A CATHETER REVISION. DURING EXPLANT, THERE WAS NOTED TO BE AN ABSENCE OF A METAL TIP ON THE DISTAL SEGMENT OF THE CATHETER. THE REMAINDER OF THE CATHETER APPEARED NORMAL, AND A DYE STUDY WAS PERFORMED INTRA-OPERATIVELY FOR VISUALIZATION/LOCATION OF THE CATHETER FOR INCISION, WHICH THE CATHETER APPEARED NORMAL WITHOUT LEAKAGE. THE PUMP WAS BEING USED TO DELIVER DILAUDID AND CLONIDINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A LEAK IN THE PATIENT'S CATHETER, CONFIRMED BY CATHETER DYE STUDY. THERE HAD BEEN NO TRAUMAS, FALLS OR ACCIDENTS. THE CATHETER WAS REPAIRED/REPLACED AND IT RESOLVED THE PAIN ISSUE. THE CAUSE OF THE EVENT WAS NEVER FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105064 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention