BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3140494 · Received May 31, 2013

    Report

    Report Number
    3004209178-2013-08480
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 7, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709 LOT# J10881R27, IMPLANTED: 2001 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT STATED THAT THEY HAD HER PUMP TURNED OFF BECAUSE SHE HAD A PUNCTURED OR SPLIT CATHETER LINE. THEY FURTHER STATED THAT THERE WAS LEAKAGE; THAT ¿IT WAS EITHER A PUNCTURE OR A KINK IN THE CATHETER LINE¿. THEY STATED THEY HAD SURGERY TO CORRECT IT; THAT THEIR HEALTHCARE PROVIDER SPLICED THE CATHETER OR THE TUBING INSIDE THAT WENT AROUND FROM THE PUMP INTO HER SPINE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE REVISION OF THE EXISTING CATHETER OCCURRED ON (B)(6) 2008. THE ROOT CAUSE OF THE ISSUE WAS A CATHETER LEAK DUE TO A CATHETER FRACTURE IN THE LUMBAR AREA. THE PATIENT EXPERIENCED REDUCED PAIN BENEFIT. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240718 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention