BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3024323 · Received March 27, 2013

    Report

    Report Number
    6000030-2013-00060
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    February 25, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT# J0039979R, IMPLANTED: 2000-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS NOTED TO HAVE HAD A CATHETER REVISION, AND THEIR PUMP WAS REPLACED IN (B)(6) 2012. THE DATE OF AND REASON FOR THE REVISION WERE UNKNOWN. NO SYMPTOMS WERE REPORTED. THE MEDICATION USED WITHIN THE SYSTEM WAS BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126122 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1