BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1747692 · Received July 2, 2010

    Report

    Report Number
    3004209178-2010-05189
    Event Type
    Injury
    Date Received
    July 2, 2010
    Date of Event
    March 1, 2010
    Report Date
    June 4, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2380-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP AND A PORTION OF THE CATHETER HAVE BEEN RETURNED TO THE MFR FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    AT THE PUMP REFILL ON (B)(4) 2010, 20 CC OF MEDICATION WAS REMOVED FROM THE PUMP DESPITE AN INCREASED RATE OVER THE MONTH; THE PT HAD NOT BEEN RECEIVING THE MEDICATION. THE PUMP WAS REPLACED. THE PT RECOVERED WITHOUT SEQUELA. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Disability| R CATHETER: MODEL 8709SC, LOT# N233893009| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG015311N| IMPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG015311N| CATHETER: MODEL 8709SC, LOT# N233893009| EXPLANTED: