BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1184485 · Received October 2, 2008

    Report

    Report Number
    2182207-2008-06274
    Event Type
    Injury
    Date Received
    October 2, 2008
    Date of Event
    March 31, 2008
    Report Date
    September 5, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: USED FOR THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN MRI IN 2008 THAT SHOWED SUBCUTANEOUS FLUID FROM L1-L5. THE CATHETER WAS REPLACED AT ABOUT 2 WEEKS LATER. THE HEALTH CARE PROVIDER INDICATED THAT THE PATIENT EXPERIENCED HYPERTONIA AND DYSTONIA (DATES NOT PROVIDED) AND THAT THE PATIENT WAS BETTER AFTER THE CATHETER REVISION. THE PUMP CONTAINED LIORESAL 2000 MCG/ML AT A DAILY DOSE OF 800-950 MCG. THE PATIENT OUTCOME WAS REPORTED AS "PATIENT RECOVERED WITHOUT SEQUELAE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention EXPLANTED| PROGRAMMER MODEL 8840 LOT# UNK| CATHETER MODEL 8709 LOT# J12510R06 IMPLANTED