BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PUMP

    MDR report key: 1082987 · Received July 28, 2008

    Report

    Report Number
    2182207-2008-04438
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    January 1, 2007
    Report Date
    July 1, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE CHILD'S NEUROLOGIST HAD SUSPECTED THAT THE CATHETER HAD A "MICRO LESION" DUE TO THE FACT THAT THE PT HAD NOT HAD GOOD THERAPEUTIC EFFECT FROM THE PUMP. THE CATHETER WAS REPLACED. THERE WAS NO PT INJURY. THE PT STATUS AFTER REPLACEMENT WAS REPORTED AS "OK". THE PUMP WAS USED TO DELIVER LIORESAL FOR THE TREATMENT OF SPASTICITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| CATHETER MODEL 8731SC LOT# UNK| IMPLANTED