BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3902120 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12261
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    June 5, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA A MANUFACTURING REPRESENTATIVE INDICATING THAT THE PATIENT HAD A CATHETER REVISION DUE TO A FLIPPED PUMP THE DOCTOR INFORMED TWO MANUFACTURING REPRESENTATIVES THAT THE PATIENT HAD A HISTORY OF TWIDDLING AND FLIPPING THE PUMP AND THAT HE HAD TO REVISE THE PATIENT'S CATHETER PREVIOUSLY IN (B)(6) 2014 (AS PREVIOUSLY REPORTED). NEITHER ONE OF THE MANUFACTURING REPRESENTATIVES WERE PRESENT FOR THAT SURGERY AND THERE WAS NO FURTHER INFORMATION TO PROVIDE REGARDING THIS EVENT

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER REVISION OR REPLACEMENT WAS DONE ON THE REPORT DATE. THE CATHETER WAS BEING REPLACED WITH AN ASCENDA CATHETER. IT WAS LATER REPORTED THAT, DURING A PUMP REPLACEMENT ON (B)(6) 2014, IT WAS DISCOVERED THAT THE CATHETER HAD TWISTED UP IN THE POCKET AND NEEDED TO BE REPLACED. THE REPLACEMENT WAS DONE ON (B)(6) 2014. SOME OF THE PREVIOUS CATHETER WAS LEFT IN THE INTRATHECAL SPACE, AND WAS STILL THERE AS OF (B)(6) 2014. INITIALLY, THE DOCTOR THOUGHT THAT HE MAY SPLICE INTO THAT, BUT AFTER FURTHER CONSIDERATION, HE DECIDED TO PLACE A WHOLE NEW CATHETER. AS OF (B)(6) 2014, THE PATIENT WAS DOING GREAT AND THE CURRENT CATHETER AND NEW PUMP WERE WORKING PROPERLY. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379412 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention