BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3761152 · Received April 21, 2014

    Report

    Report Number
    3004209178-2014-07549
    Event Type
    Injury
    Date Received
    April 21, 2014
    Report Date
    March 31, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY. ANALYSIS OF THE CATHETER REVEALED NO SIGNIFICANT ANOMALY, SC CONNECTOR NON SIGNIFICANT INDENT IN THE SEAL DID NOT AFFECT INFUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FEVER AND DRAINAGE/INCISIONAL WOUND OPENING AT THE DEVICE POCKET. HOSPITALIZATION AND AN EXPLANT WERE REQUIRED. AT THE TIME OF THIS REPORT, THE PATIENT STATUS WAS INDICATED TO BE ¿ALIVE-NO INJURY¿. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. IT WAS LATER REPORTED THAT A CULTURE WAS OBTAINED FROM THE PUMP POCKET AND WAS NEGATIVE AS OF 2014 (B)(6). THERE WAS NO DOCUMENTED INFECTION. NO OTHER DIAGNOSTICS WERE DONE. THE PATIENT WAS GIVEN ANTIBIOTICS. THE PUMP WAS EXPLANTED IN THE CATHETER WAS LEFT IN PLACE. THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) AND WAS ¿DOING OKAY¿. IT WAS LATER REPORTED THAT FLUID STARTED BUILDING UP AROUND THE PUMP AREA AND THE PATIENT GOT AN INFECTION. THE PATIENT HAD AN EMERGENCY SURGERY ON 2014 (B)(6) TO HAVE THE PUMP REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240491 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R