BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 2231109 · Received August 26, 2011

    Report

    Report Number
    3007566237-2011-06919
    Event Type
    Injury
    Date Received
    August 26, 2011
    Report Date
    August 5, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PUMP INFECTION WAS REPORTED AS HAVING OCCURRED, FOLLOWED BY EXPLANT IN 2004. THE PATIENT HAD REMAINED W/O BACLOFEN FOR (B)(6). WITHDRAWAL SYNDROME DID NOT DEVELOP. IT WAS NOTED THAT THE PLAN WAS TO REMOVE THE PATIENT'S PUMP AND CATHETER, AND REPLACE THE INTRATHECAL BACLOFEN WITH OTHER ORAL ANTISPASMODIC MEDICATIONS. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention