BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2190379 · Received July 25, 2011

    Report

    Report Number
    3004209178-2011-05762
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    February 28, 2011
    Report Date
    July 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    FOLLOWING PUMP IMPLANT THE PATIENT NEVER HAD PAIN RELIEF. ON (B)(6) 2011, A ROTOR STUDY SHOWED NO ANOMALY. BUT THE CATHETER COULD NOT BE ASPIRATED NOR FLUSHED THROUGH SIDE PORT OF THE PUMP. X-RAY SHOWED DISLOCATED CATHETER IN PUMP POCKET. ON (B)(6) 2011 CATHETER WAS REPLACED. ON (B)(6) 2011, REFILL SHOWED EFFECTIVE VOLUME IN PUMP 40ML WHEREAS THE NVISION SHOWED 21ML. ON (B)(6) 2011, REFILL SHOWED 39.5 ML EFFECTIVE VOLUME, NVISION SHOWED 28.2ML. THE X-RAY OF THE SECOND CATHETER SHOWED A NORMAL LOCATION OF THE CATHETER, HOWEVER, IT WASN'T POSSIBLE TO ASPIRATE FROM NOR FLUSH THE CATHETER. ON (B)(6) 2011, THE PUMP POCKET WAS OPENED AND AT FIRST SIGHT NOTHING ABNORMAL WAS VISIBLE. THE CATHETER WAS DISCONNECTED FROM THE PUMP AND NORMAL CEREBROSPINAL FLUID (CSF) FLOW WAS OBSERVED AND 3CC OF CSF WAS ASPIRATED FROM THE CATHETER WHICH SHOWED THAT THE TIP IS IN THE INTRATHECAL SPACE. CONTRAST FLUID FLUSHED IN THE CATHETER CONFIRMED THIS TIP LOCATION. THE PUMP SIDEPORT COULD BE FLUSHED AS WELL. THE SUTURELESS PUMP CONNECTOR OF THE CATHETER WAS REPLACED USING REVISION KIT 8578 WITH SERIAL NUMBER (B)(4). HOWEVER, WHEN CONNECTED TO THE PUMP ONCE AGAIN FLUSHING OR ASPIRATING WEREN'T POSSIBLE WITH THE CATHETER. THE PHYSICIAN WAS CONVINCED THAT THERE WAS A PROBLEM WITH THE PUMP CONNECTOR WHEN CONNECTED TO THE CATHETER. SO THE PHYSICIAN REPLACED THE PUMP WITH A NEW PUMP. SINCE HE WAS SO CONVINCED THAT THE OLD PUMP WAS THE PROBLEM, THE PHYSICIAN DID NOT WANT TO TRY ASPIRATING FROM THE SIDE PORT OF THE NEW PUMP. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| CATHETER: MODEL 8709SC, LOT# 0204421661| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# 0204978435| EXPLANTED:| EXPLANTED: