BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2892904 · Received January 2, 2013

    Report

    Report Number
    3004209178-2013-00034
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8780 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTED TO BE HOSPITALIZED AND HAD EXPERIENCED WITHDRAWAL-LIKE SYMPTOMS, PAIN, INCREASED SPASTICITY, UNDERDOSE SYMPTOMS, A BURNING SENSATION ON THEIR SKIN, AND LESS THAN 50% THERAPY RELIEF. THE PATIENT WAS NOTED TO BE ALIVE AND WITH INJURY AS OF THE DATE OF THIS REPORT. THE PATIENT WAS REPROGRAMMED, THEIR DOSE WAS INCREASED, AND THEY WERE SCHEDULED TO SEE THEIR PHYSICIAN ONCE DISCHARGED. THE MEDICATION USED WITHIN THE SYSTEM WAS LIORESAL. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. THE PATIENT HAD NOT PRESENTED TO THE OFFICE FOR ALMOST 3 WEEKS AND STATED THAT SHE WAS MUCH BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization