BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 3015790 · Received March 21, 2013

    Report

    Report Number
    3004209178-2013-04063
    Event Type
    Death
    Date Received
    March 21, 2013
    Date of Event
    April 28, 2010
    Report Date
    February 22, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, LOT# N233815, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PATIENT DEATH ON THE DAY AFTER IMPLANT. THE DRUG USED IN THIS SYSTEM WAS AN OPIOID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117627 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Death