BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2864130 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11354
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 8, 2012
    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
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2002 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID, 8578 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S CATHETER WAS FRACTURED. IT WAS INDICATED FOLLOWING A PUMP REPLACEMENT THAT THE CATHETER APPEARED FINE DURING THE PROCEDURE WITH GOOD CEREBRAL SPINAL FLUID (CSF) FLOW. IT WAS NOTED TOWARDS THE END OF THAT SAME WEEK, THE PATIENT EXPERIENCED A RETURN OF BACK PAIN, NAUSEA AND HEADACHE. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WAS ADMITTED TO THE HOSPITAL. THE CATHETER FRACTURE WAS CONFIRMED VIA X-RAY IMAGING. THE CATHETER WAS REVISED AND A PORTION OF THE CATHETER WAS REPLACED. AT THE TIME OF THIS REPORT THE PATIENT WAS ALIVE AND WITHOUT INJURY. THE DRUG DELIVERED VIA PUMP WAS DILAUDID. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization| R