BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3020004 · Received March 25, 2013

    Report

    Report Number
    3004209178-2013-04206
    Event Type
    Injury
    Date Received
    March 25, 2013
    Report Date
    February 25, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8578 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 8709 LOT# J0039979R, IMPLANTED: 2000 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID, 8840 LOT#, PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID, 8840 LOT#, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    FOLLOWING A NEW PUMP IMPLANT, IT WAS REPORTED THAT A CATHETER REVISION HAD BEEN PREVIOUSLY PERFORMED BECAUSE, THEY WERE UNABLE TO ASPIRATE DURING A DYE STUDY. IT WAS FOUND THAT THE CATHETER WAS KINKED AND THEY SAW DYE "WHERE THE CONNECTOR PIN AND SPINAL SEGMENT ACTUALLY CONNECT". THE PREVIOUS REVISION HAD ADDED AN 8575 CATHETER TO AN EXISTING 8709. THE NEW CATHETER WAS ASPIRATED AFTER THE PUMP SURGERY, AND IT WAS UNCLEAR WHAT PRIMING VOLUME SHOULD BE PROGRAMMED. A PRIOR REVISION INDICATED THAT 81.4 CM HAD BEEN REMOVED, BUT THIS WAS THOUGHT TO BE INACCURATE. THE LENGTH OF THE CATHETER IN THE PATIENT WAS UNKNOWN. THE PATIENT WAS NOTED TO BE ON A STEADY DOSE OF BACLOFEN, AND THEN "HE STARTED DEVELOPING SPASTICITY". NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS HAVING MORE SPASTICITY. THE PAIN DOCTOR ATTEMPTED THE DYE STUDY BUT WAS UNABLE TO ASPIRATE. IT APPEARED THAT THERE WAS A KINK IN THE SPINAL SEGMENT OF THE CATHETER. THE SURGEON ATTEMPTED TO ASPIRATE THE ENTIRE CATHETER WITHOUT SUCCESS. HE THEN DISCONNECTED THE CATHETER AND CATHETER PIN CONNECTOR AND OBSERVED DRIPPING. THE CATHETER AND PIN CONNECTOR WERE RECONNECTED AND AGAIN OBSERVED DRIPPING. HE THEN FLUSHED THE CATHETER ACCESS PORT WITHOUT DIFFICULTY. THE CATHETER WAS THEN RECONNECTED TO THE PUMP AND THE SURGEON WAS ABLE TO ASPIRATE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS UNKNOWN. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN. IT WAS LATER REPORTED THAT THE CATHETER DYE STUDY WAS PERFORMED ON (B)(6) 2012 AND SHOWED THE CATHETER WAS KINKED BEHIND THE PUMP IN THE PROXIMAL SEGMENT. THE REVISION TOOK PLACE ON (B)(6) 2013. THE PATIENT RECOVERED WITHOUT SEQUELAE AND WAS WITHOUT INJURY AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121837 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention