BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203576 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-11220
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PUMP AND CATHETER REPLACEMENT ON 2013-(B)(6) THE CATHETER WAS FOUND TO BE FRACTURED AT THE LUMBAR SITE ¿RIGHT WHERE IT GOES INTO THE INTRATHECAL SPACE¿. THE SURGEON WAS UNABLE TO RETRIEVE THE LUMBAR PORTION OF THE CATHETER AS THE PORTION RETRACTED INTO THE INTRATHECAL SPACE. IT WAS INDICATED THAT A DYE STUDY HAD BEEN PERFORMED THAT SHOWED THE LOCATION OF THE FRACTURE. THE DEVICE SYSTEM DELIVERED DILAUDID. IT WAS LATER REPORTED THAT THE CATHETER BROKE AT THE LUMBAR ANCHOR SITE. THERE WERE NO PATIENT SYMPTOMS. IT WAS LATER REPORTED THAT THE BROKEN PORTION OF THE CATHETER MIGRATED INTO THE INTRATHECAL SPACE. THE NEUROSURGEON LEFT THE MIGRATED PORTION OF THE CATHETER IN THE INTRATHECAL SPACE AND REPLACED THE CATHETER. PATIENT STATUS AT THE TIME OF THE REPORT WAS WITH NO INJURY OR ADVERSE EVENT.

    Description of Event or Problem · 1

    PER THE PATIENT, WHEN THE CATHETER WAS IMPLANT, THE DOCTOR HAD TO SHAVE PART OF HER VERTEBRAE DURING THE SURGERY BECAUSE SHE HAD TOO MUCH SCARING AND CALCIFICATION FOR THEM TO PLACE THE CATHETER WHERE THEY NORMALLY WOULD. THE PATIENT WAS ¿HYPER-MOBILE¿ AND THEY BELIEVED THAT 2-3 WEEKS AFTER IMPLANT, THE SHAVED VERTEBRAE CAUSED THE CATHETER TO SHEAR. IT TOOK A YEAR FOR THEM TO REALIZE THIS BY DOING A DYE STUDY AFTER THE PATIENT REPORTED NO PAIN RELIEF. THE PUMP WAS DELIVERING DURAMORPH AND DILAUDID AT THE TIME OF THE CATHETER ISSUE. A ¿HEAVIER GAUGE" CATHETER WAS USED DURING THE REPLACEMENT PROCEDURE, SO ¿IT IS NOT SUPPOSED TO BE SHEARED¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306452 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention