BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2981449 · Received February 27, 2013

    Report

    Report Number
    3004209178-2013-03129
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    January 31, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PATIENT'S CATHETER REVISION ON (B)(6), THE PATIENT HAD ALMOST IMMEDIATE RELIEF OF SPASTICITY. IT WAS THEN LEARNED THAT THE PATIENT WAS BEING TREATED FOR AN INFECTION. THE PATIENT STATUS WAS NOTED TO BE ALIVE WITH INJURY. MEDICAL INTERVENTION WAS REQUIRED. THE DEVICE REMAINED IMPLANTED AT THAT TIME. NO OTHER DETAILS WERE KNOWN. THE PUMP WAS BEING USED TO DELIVER GABLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84781 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention