BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4171611 · Received October 14, 2014

    Report

    Report Number
    3007566237-2014-02986
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    September 18, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS FILED AS MFR. REPORT # 3007566237. ADDITIONAL REVIEW SHOWED THE CORRECT MANUFACTURING SITE WAS SITE # 3004209178. THE IMPLANT DATE OF THE KNONWN SERIAL NUMBER WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER; PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDERDOSE SYMPTOMS; NOT GETTING RELIEF OF SPASTICITY. IT WAS THOUGHT THAT THERE WAS A POSSIBLE CATHETER OCCLUSION. X-RAYS AND A DYE STUDY WERE PERFORMED. THE HEALTHCARE PROVIDER (HCP) HAD DIFFICULTY WITHDRAWING 1ML OF FLUID FROM THE CATHETER ACCESS PORT (CAP) AND COULD NOT PUSH ANY DYE THROUGH. IT WAS STATED THAT A REVISION WAS PLANNED, BUT NOT YET SCHEDULED. THE PATIENT¿S STATUS AT THE TIME OF THE EVENT WAS SAID TO BE ALIVE AND NO INJURY. THE PATIENT WAS TAKING ORAL BACLOFEN. THE PUMP WAS USED TO DELIVER BACLOFEN (UNKNOWN). NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS DISCHARGED AS STABLE. THE PUMP WAS USED TO DELIVER GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650164 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention