BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHOMED II

    MDR report key: 1161198 · Received September 15, 2008

    Report

    Report Number
    2182207-2008-05743
    Event Type
    Injury
    Date Received
    September 15, 2008
    Report Date
    August 18, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: HOVING MA, ET AL. SAFETY AND ONE-YEAR EFFICACY OF INTRATHECAL BACLOFEN THERAPY IN CHILDREN WITH INTRACTABLE SPASTIC CEREBRAL PALSY. EUROPEAN JOURNAL OF PEDIATRIC NEUROLOGY; 2008: O5.200 P1-10. THE AIM OF THE ARTICLE IS TO STUDY THE EFFICACY AT 12 MONTHS AND SAFETY UP TO 24 MONTHS AFTER START OF CONTINUOUS INTRATHECAL BACLOFEN INFUSION, (CITB) IN CHILDREN WITH INTRACTABLE SPASTIC CEREBRAL PALSY. REPORTABLE EVENT: CASE 11, A MALE, PROCEDURAL AND DEVICE AE'S INCLUDED: WOUND LEAKAGE POST OP, ONE FLUID DROP OBSERVED AT LUMBAR WOUND, WITH ONE EXTRA SUTURE GOOD FURTHER WOUNDING HEALING. SWELLING AT PUMP SITE POSTOP. RESOLVED BY A TEMPORARY PRESSURE DRESSING. PUMP MOVED CAUDALLY, NONSYMPTOMATIC. SEE MFG REPORT 2182207200805741.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHOMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other| R PROGRAMMER MODEL UNK N=1| CATHETHER MODEL 8731 N=1