BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1000148 · Received February 19, 2008

    Report

    Report Number
    2182207-2008-00791
    Event Type
    Injury
    Date Received
    February 19, 2008
    Report Date
    January 25, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    JOURNAL REFERENCE: MOTTA ET AL. "UPPER LIMB FUNCTION AFTER INTRATHECAL BACLOFEN TREATMENT IN CHILDREN WITH CEREBRAL PALSY." J PEDIATR ORTHOP 2008; 28(1): 91-96. THIS ARTICLE DESCRIBES A STUDY OF 20 CHILDREN WITH SPASTIC CP BETWEEN THE AGES OF 5 AND 15 YEARS THAT RECEIVED INTRATHECAL BACLOFEN TREATMENT. REPORTABLE EVENT: TWO PATIENTS IMPLANTED WITH SYNCHROMED PUMPS FOR SPASTIC CP HAD CATHETERS RUPTURE AND REQUIRED CATHETER REPLACEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention IMPLANTABLE INFUSION PUMP MODEL 8627| PROGRAMMER MODEL UNK