BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2895435 · Received January 3, 2013

    Report

    Report Number
    3004209178-2013-00121
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 6, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PATIENT PROGRAMMER: MODEL 8835, SERIAL# UNKNOWN, IMPLANTED: NA, EXPLANTED: NA. CATHETER: MODEL 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. (B)(4). NODULE ON PATIENT'S BACK FROM CATHETER ANCHOR.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A CATHETER ANCHOR WAS REVISED. THERE WAS A "NODULE" NOTED ON PATIENT'S BACK. HEALTH CARE PROVIDER WAS NOT CERTAIN IF NODULE WAS A CEREBRAL SPINAL FLUID LEAK OR THE CATHETER. X-RAY CONFIRMED CATHETER TIP IN INTRATHECAL SPACE. PATIENT CONTINUED TO GET "FAIR" PAIN RELIEF. IT WAS NOTED DURING REVISION THAT AN ANCHOR HAD "POPPED LOOSE" AND WAS RE-SUTURED. THERE WERE NO COMPLICATIONS. THE DEVICE SYSTEM WAS USED TO INFUSE FENTANYL. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS A CEREBROSPINAL FLUID LEAK AROUND THE CATHETER. THE PHYSICIAN HAD ATTEMPTED A "PURSE STRING SUTURE", BUT THE LEAK WAS NOT RESOLVED. AT THE TIME OF REPORT, THE PUMP WAS SET TO MINIMUM RATE. IT WAS BELIEVED THAT THE PATIENT WAS RECEIVING ANOTHER FORM OF PAIN MEDICATION UNTIL A CATHETER REVISION COULD BE PERFORMED. THE PATIENT'S CONDITION WAS UNKNOWN, BUT THE REPORTER BELIEVED, THE PATIENT HAD INCREASED PAIN. FIVE DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SEVERE HEADACHES AS WELL AS FLUID BUILDUP AT THE SPINAL SITE. THE LEAK WAS LOCATED WHERE THE CATHETER WAS ANCHORED AT THE SPINE. IT WAS STATED THAT THERE WAS NO BREAK OR TEAR IN THE CATHETER, BUT THE CATHETER WAS REPLACED. AT THE TIME OF REPORT, THE PATIENT WAS "DOING WELL" AND WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2391 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention