BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3884307 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-11816
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER; PRODUCT ID NEU_UNKNOWN, SERIAL# UNKNOWN, PRODUCT TYPE UNKNOWN; PRODUCT ID NEU_UNKNOWN, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE UNKNOWN; PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAD BEEN AN ANCHOR ISSUE. IT WAS REPORTED THAT THE PHYSICIAN PLACED ANCHORING DEVICE OVER CATHETER INTRAOPERATIVELY, HE DEPLOYED THE DEVICE AND NOTED MORE RESISTANCE THAN HE NORMALLY EXPERIENCES. THE CATHETER HAD BEEN DRIPPING CEREBRAL SPINAL FLUID (CSF) CONSISTENTLY. THE PHYSICIAN NOTED THE CSF HAD STOPPED DRIPPING FOR A SHORT TIME. IT WAS NOTED THAT THE PHYSICIAN WAS LOOKING AT THE INCISION AND NOTED THE ANCHOR WAS NOT SETTING ON THE CATHETER NORMALLY. IT WAS NOTED THAT USUALLY THE ANCHOR WAS TAPERED AT EACH END. IT WAS NOTED THAT THE END CLOSEST TO THE FASCIA WAS ROLLED ONTO ITSELF, LIKE IT FOLDED AT THE END OF THE ANCHOR AND WAS NOT SMOOTH AGAINST THE CATHETER. IT WAS NOTED THAT THE PHYSICIAN DID NOTHING TO THE ANCHOR YET BUT NOTED CSF FLOW WAS DRIPPING AGAIN. IT WAS NOTED THAT THEY WERE NOT SURE WHY CSF FLOW HAD STOPPED FOR THAT SHORT PERIOD OF TIME. PHYSICIAN DID NOT FEEL COMFORTABLE LEAVING THE ANCHOR ON SO HE REMOVED THE ANCHOR AND ADDED A NEW ANCHOR WHICH DID NOT HAVE ANY ISSUES. IT WAS NOTED THAT THE CATHETER WAS PATENT WITH CSF AND NO FURTHER ISSUES WERE NOTED WITH THE IMPLANT. THE PUMP SYSTEM WAS DELIVERING MORPHINE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS ONLY THE ANCHOR PROVIDED IN THE CATHETER KIT. IT WAS NOTED THAT IT DID NOT AFFECT THE PATIENT AT ALL. THE PHYSICIAN REMOVED THE ANCHOR WITHOUT INCIDENT AND REPLACED WITH ANOTHER ANCHOR FROM ANOTHER KIT. IT WAS NOTED THAT THERE WERE NO PATIENT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360080 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR