BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2052639 · Received April 7, 2011

    Report

    Report Number
    3004209178-2011-02664
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    January 1, 2010
    Report Date
    July 6, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURE EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PUMP SYSTEM WAS EXPLANTED AND NOT REPLACED DUE TO INFECTION. THE PUMP CONTAINED LIORESAL. IT WAS REPORTED THERE WAS NO PATIENT INJURY. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N232612009