BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 3142864 · Received June 3, 2013

    Report

    Report Number
    3007566237-2013-01835
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE RETURNED CATHETER SEGMENT REVEALED SIGNIFICANT TWISTING THAT MAY HAVE AFFECTED INFUSION.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP REFILL PHYSICIAN FELT THAT THE PUMP HAD FLIPPED WHEN HE LAST TRIED TO FILL IT. THE PATIENT WAS SCHEDULED FOR A PUMP REVISION. WHEN THE PUMP POCKET WAS OPENED THE PUMP WAS FOUND CORRECTLY ORIENTED, HOWEVER, IT WAS EVIDENT THAT THE PATIENT HAD ROTATED/FLIPPED HER PUMP MANY TIMES WHICH HAD RESULTED IN A TOTAL TWISTING OF HER CATHETER AND A TOTAL TEAR OF THE PUMP SEGMENT AT THE PUMP CONNECTION POINT. THERE WAS FLUID, ASSUMED TO BE DRUG/CSF, IN HER PUMP POCKET. THE PUMP SEGMENT PIECE WAS REMOVED AND REPLACED WITH A NEW PUMP REVISION SEGMENT PIECE, HER SPINAL SEGMENT WAS FOUND TO BE PATENT AND STILL DELIVERING CSF BACKFLOW ONCE UNTWISTED. THE SURGEON WAS CONFIDENT THAT THE SPINAL SEGMENT HAD NOT BEEN COMPROMISED. THE PUMP WAS SECURED SUB-FASCIAL TO PREVENT THE PATIENT FROM "TWIDDLING" AGAIN. THE PUMP SEGMENT WHICH WAS TORN DEMONSTRATED FRAYED LAMINA AND WAS BEING SENT BACK FOR ANALYSIS. THERE WAS NO PATIENT INJURY. IT WAS LATER REPORTED THAT THE PUMP WAS USED TO DELIVER MORPHINE SULFATE WHICH INFUSED AT MINIMUM RATE. IT HAD BEEN SWITCHED TO MINIMUM RATE BY MANAGING PHYSICIAN BEFORE SURGERY WHEN HE WAS UNABLE TO ACCESS THE PUMP. THE PATIENT HAD PAIN AND HAD SEVERAL ORAL PAIN MEDICATIONS. IT WAS UNKNOWN HOW THE PATIENT WAS FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243389 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention