BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3053074 · Received April 11, 2013

    Report

    Report Number
    3004209178-2013-06020
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 28, 2013
    Report Date
    June 13, 2016
    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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 85 96SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: A CSF (CEREBROSPINAL FLUID) LEAK WAS OBSERVED DURING THE CATHETER REVISION; CSF LEAKED INTO THE SURGICAL FIELD. THE CSF LEAK WAS OVERSEWN WITH INTERRUPTED LIGATURES DURING THE CATHETER REVISION ON (B)(6) 2013. THE SEVERITY OF THE EVENT WAS NOTED TO BE ¿MODERATE¿. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT A MEDICATION ADJUSTMENT WAS MADE; THE PATIENT¿S OXYCODONE DOSE WAS CHANGED FROM 5MG TO 10 MG TABLETS. A CATHETER REVISION WAS PENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PAIN HAD BEEN STEADILY INCREASING FOR SEVERAL MONTHS AND IT FELT AS THOUGH HER BOLUS WAS NOT ALWAYS WORKING. IT WAS ALSO NOTED THAT THE PATIENT HAD FALLEN DOWN EIGHT STAIRS LAST MONTH. A CATHETER ACCESS PORT (CAP) CONTRAST STUDY WAS PERFORMED AND THE CONTRAST WAS OBSERVED EXITING THE CATHETER TIP AT THE 8TH THORACIC VERTEBRA. IT WAS NOTED THE CATHETER HAD MIGRATED CAUDALLY FROM THE 4TH THORACIC VERTEBRA TO THE 8TH. AT THE TIME OF THE REPORT, THE EVENT WAS CONSIDERED ONGOING. THE DEVICE SYSTEM WAS BEING USED TO DELIVER HYDROMORPHONE, BUPIVACAINE, AND FENTANYL.

    Description of Event or Problem · 1

    THE PUMP WAS EXPLANTED AND RETURNED DUE TO END OF LIFE. THERE WAS NO ALLEGATION AGAINST THE PUMP.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154463 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention