BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1559452 · Received December 10, 2009

    Report

    Report Number
    3007566237-2009-09249
    Event Type
    Injury
    Date Received
    December 10, 2009
    Date of Event
    November 23, 2009
    Report Date
    December 1, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: MOTTA F, ANTONELLO CE, STIGNANI C. UPPER LIMBS FUNCTION AFTER INTRATHECAL BACLOFEN THERAPY IN CHILDREN WITH SECONDARY DYSTONIA. J PEDIATR ORTHOP. 2009; 29(7): 817-821. SUMMARY: THIS ARTICLE PRESENTS A STUDY TO DETERMINE WHETHER THE EFFECTS OF INTRATHECAL BACLOFEN THERAPY IN PTS WITH DYSTONIC CEREBRAL PALSY, IN ADD'L TO REDUCING DYSTONIA, MAY ALSO IMPROVE UPPER LIMB FUNCTION. ELEVEN PTS WERE ASSESSED BEFORE TREATMENT AND 12 MONTHS AFTER IMPLANT. REPORTABLE EVENT: ONE CATHETER RUPTURE OCCURRED. THE CATHETER WAS SUBSEQUENTLY REPLACED. NO PT SYMPTOMS OR OUTCOME WAS REPORTED. IN 2009, ALLEGATION OF PRODUCT FAILURE.

    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| EXPLANTED:| PROGRAMMER: MODEL UNK, LOT#: UNK| IMPLANTED: