BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3040188 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04802
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    June 26, 2012
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, LOT # N184776001, IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PUMP WAS FLIPPING. THE PUMP WAS REVISED. THE PATIENT "DID WELL" POST REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2009, THE PATIENT HAD TO HAVE A PUMP REVISION AS IT WAS TRYING TO FLIP, AND THEN HAD TO "HAVE IT FIXED." THE MEDICATION BEING DELIVERED WAS BACLOFEN. NO FURTHER EVENT DETAILS WERE PROVIDED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143365 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Required Intervention