BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3193436 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-10976
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 4, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, LOT# N184208006, IMPLANTED: 2009-(B)(6) PRODUCT TYPE CATHETER PRODUCT ID 8578, LOT# N160042011, IMPLANTED: 2009-(B)(6), (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT¿S PUMP DIED WITHIN LESS THAN 2 YEARS. PER THE REPORTER, PATIENT NO LONGER HAD A MDT DEVICE AND WAS UNCLEAR IF THE PATIENT STILL HAD A SYSTEM IMPLANTED. THE PUMP WAS USED TO DELIVER DILAUDID. FURTHER INFORMATION 2 WEEKS LATER INDICATED THE PATIENT HAD NO PROBLEMS WITH HER ¿PAIN POUCH¿ EXCEPT THE "LONG TRIPS" SHE HAS HAD TO TAKE TO GET IT ¿ADJUSTED¿. THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291659 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1