BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3800322 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08736
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 15, 2014
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8711, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MANUFACTURER REPRESENTATIVE HAD JUST LEARNED THAT A CATHETER REVISION PROCEDURE WAS SCHEDULED FOR THE DAY FOLLOW THE DATE OF THIS REPORT. THE REPRESENTATIVE DIDN¿T KNOW THE TYPE OF REVISION, WHY OR WHEN AT THE TIME OF THE REPORT AND PLANNED TO UPDATE THE EVENT ONCE SHE LEARNED MORE. NO FURTHER INFORMATION WAS PROVIDED. THE TYPE OF MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT PROVIDED. IT WAS LATER REPORTED THAT THE DEVICE SYSTEM DELIVERED FENTANYL. SYMPTOMS THE PATIENT EXPERIENCED HAD INCLUDED INEFFECTIVE THERAPY, INCREASED PAIN AND A FLUID LUMP NEAR THEIR SPINE. THE HEALTH CARE PROVIDER (HCP) HAD DONE A DYE STUDY IN THE OFFICE HOWEVER THE DEVICE MANUFACTURER REPRESENTATIVE WAS UNSURE OF THE DATE OF THE PROCEDURE. THE ISSUE WITH THE CATHETER WAS THAT THE SPINAL PORTION HAD A TEAR NEAR THE PIN CONNECTOR OF THE TWO PIECE CATHETER. AS A RESULT, THE DISTAL PORTION WAS REPLACED. THE PATIENT WAS NOW DOING WELL AND RECEIVING EFFECTIVE THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277466 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention