BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2874740 · Received December 15, 2012

    Report

    Report Number
    3004209178-2012-11882
    Event Type
    Injury
    Date Received
    December 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR EXCRUCIATING BACK PAIN. THE PATIENT FELL 6 WEEKS PRIOR TO THE REPORT AND IT WAS UNCLEAR IF THE WORSENING PAIN WAS RELATED TO THE FALL OR IF THE PATIENT HAD ANOTHER "BULGE IN HIS BACK." THE REPORTER STATED THAT THE PAIN WAS HORRIBLE AND "SOMETHING'S NOT RIGHT." AN MRI WAS ANTICIPATED. IT WAS UNKNOWN WHAT DRUG WAS DELIVERED BY THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization