BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2992473 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03432
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8835 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 8598A LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID, 8596SC LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SPINAL HEADACHE AND CEREBROSPINAL FLUID (CSF) LEAK. AN EPIDURAL BLOOD PATCH WAS DONE. A SURGICAL REVISION WAS PERFORMED AND THE CATHETER WAS SPLICED. THE PATIENT OUTCOME WAS NOTED TO BE RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013. THE PUMP WAS BEING USED TO DELIVER FENTANYL AND BUPIVACAINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING THE CATHETER REVISION SURGERY, A PURSE STRING SUTURE WAS PLACED AROUND THE CATHETER DURAL EXIT SITE. ANOTHER EPIDURAL BLOOD PATCH WAS DONE ON (B)(6) 2013. THE PATIENT OUTCOME WAS NOTED TO BE RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97311 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention