BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1489582 · Received September 25, 2009

    Report

    Report Number
    2182207-2009-06835
    Event Type
    Injury
    Date Received
    September 25, 2009
    Date of Event
    September 21, 2009
    Report Date
    September 22, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: JAGATSINH Y. INTRATHECAL BACLOFEN: IT'S EFFECTS ON SYMPTOMS AND ACTIVITIES OF DAILY LIVING IN SEVERE SPASTICITY DUE TO SPINAL CORD INJURIES: A STUDY. INDIAN J ORTHOP. 2009; 43(1): 46-9. SUMMARY: THIS ARTICLE PRESENTS A SINGLE-SITE OPEN-LABEL PILOT STUDY OF 37 ADULT PTS IMPLANTED WITH AN INTRATHECAL BACLOFEN DRUG DELIVERY SYSTEM BETWEEN 2002 AND 2006 FOR THE TREATMENT OF SEVERE SPASTICITY, DUE TO SPINAL CORD ORIGIN. THE AIM OF THE STUDY WAS TO FIND OUT WHETHER IMPLANTATION OF THE PUMP HAD ACTUAL BENEFITS IN THESE PTS IN RELIEVING SYMPTOMS, AND FUNCTIONAL IMPROVEMENT IN THEIR ACTIVITIES OF DAILY LIVING. FURTHER, ANY BENEFICIAL EFFECT OF INTRATHECAL BACLOFEN THERAPY ON BLADDER AND BOWEL FUNCTION WAS ALSO NOTED. THE STUDY WAS CONDUCTED USING A QUESTIONNAIRE, 24 RESPONSES WERE RECEIVED, AND INCLUDED IN THE STUDY. REPORTABLE EVENT: ONE PT HAD WORSENING OF SYMPTOMS INCLUDING WORSENED MOBILITY, SOCIAL/RECREATIONAL ACTIVITIES, DRIVING ABILITY, STRENGTH, COORDINATION/DEXTERITY, AND SLEEP. CATHETER LEAKAGE WAS NOTED AFTER INVESTIGATION. A CATHETER CHANGE WAS PERFORMED. THE PT SHOWED IMPROVEMENT AFTER RECITATION OF CATHETER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER: MODEL UNK, LOT# UNK| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL UNK, LOT# UNK