BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 366688 · Received December 11, 2001

    Report

    Report Number
    2182207-2001-00819
    Event Type
    Injury
    Date Received
    December 11, 2001
    Report Date
    May 24, 2001
    Manufacturer
    MEDTRONIC INC
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE REPORT OF PATIENT RECEIVING INTRATHECAL MORPHINE WHO REQUIRED ESCALATING DOSES FOR PAIN CONTROL. FIVE YEARS AFTER IMPLANT, DEVELOPED PARAPARESIS AND SEVERE RADIATING LOW BACK PAIN. HAD INTRATHECAL MASS REMOVED AND HAS RECOVERED FULL FUNCTION OF LOWER EXTREMITIES. ANDERSON, SUSAN R., ORBEGOZO, MAURICIO, RACZ, GABOR, RAJ, P. PRITHVI, "INTRATHECAL GRANULOMA IN PATIENTS RECEIVING HIGH-DOSE INTRATHECAL MORHINE THERAPY: A REPORT OF TWO CASES" PAIN PRACTICE, VOLUME 1, NUMBER 1 2001 61-67.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55836 SYNCHROMED CATHETER LKK MEDTRONIC INC CATHETER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization UNK.| PUMP MODEL PUMP LOT# UNKNOWN IMPLANT: UNK EXPLANT: