BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1161199 · Received September 15, 2008

    Report

    Report Number
    2182207-2008-05741
    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

    Additional Manufacturer Narrative · 1

    CATHETER.

    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 8 A MALE, PROCEDURAL AND DEVICE AE'S INCLUDED; INCOMPLETE OPERATION, THE SPINAL CATHETER COULD NOT BE INSERTED FURTHER THAN 10 CM. AFTER INTERVENTION, THE CATHETER TIP COULD EASILY BE MOVED TO THE MIDTHORACIC LEVEL. NON-PROCEDURE OR DEVICE RELATED AE'S INCLUDED: URINARY HESITANCY, PAROXYSMAL DIZZINESS, PAROXYSMAL PALENESS, EPILEPTIC SEIZURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention PROGRAMMER MODEL UNK N=1| CATHETHER MODEL 8731 N=1