BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3021488 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04246
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    February 27, 2013
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8598A LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID, 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF NO PAIN RELIEF, SAYING THAT SHE HAD NOT HAD PAIN RELIEF FOR A VERY LONG TIME, IF EVER. THE PATIENT HAD NO SIGNS OR SYMPTOMS OF WITHDRAWAL. THE PHYSICIAN OPTED TO NOT DO ANY DIAGNOSTICS, BUT REPLACED THE CATHETER ENTIRELY. A CATHETER ISSUE WAS NOTED. THE PATIENT WAS HOSPITALIZED. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS NOTED TO BE ALIVE - NO INJURY/NO ADVERSE EVENT. THE PUMP WAS BEING USED TO DELIVER INFUMORPH.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS 'FEELING BAD ALL OVER' WHEN THE EVENT OCCURRED. THE REPORTER INDICATED THE CAUSE OF THE ISSUE WAS UNKNOWN BUT THE ENTIRE CATHETER WAS REPLACED AND THE PATIENT 'STILL HURTS.' THE PUMP WAS DELIVERING MORPHINE 25MG/ML AT 1.65MG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124531 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R