BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1960950 · Received January 11, 2011

    Report

    Report Number
    3007566237-2011-00237
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 16, 2010
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD 2 CATHETER REVISIONS, BUT WAS STILL NOT REACHING EFFICACY. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 EXPLANTED:| IMPLANTED:| CATHETER: MODEL CATHETER, LOT #UNKNOWN