BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4090271 · Received September 15, 2014

    Report

    Report Number
    3004209178-2014-17042
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 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 THE ¿PUMP WAS BROKE¿ AND THE ¿TUBE DISCONNECTED FROM THE PUMP¿. THE REPORTER DID NOT KNOW WHEN IT HAPPENED, BUT THAT IT WAS DISCOVERED WHEN ANOTHER MANUFACTURER¿S SCS (SPINAL CORD STIMULATOR) WAS IMPLANTED IN JUNE. THE PATIENT HAD BEEN COMPLAINING TO THEIR DOCTOR FOR A YEAR THAT SOMETHING WAS WRONG; THEY HAD LOST OVER 70 POUNDS AND HAD LOST THEIR FAMILY DUE TO DIVORCE. THE REPORTER ALSO NOTED THAT THEY EXPERIENCED EMOTIONAL DISTRESS RELATED TO THE PUMP. THE PUMP WAS BEING USED TO DELIVER SUFENTANIL. NO INTERVENTIONS OR OUTCOME WERE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568409 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR