BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 2141215 · Received June 22, 2011

    Report

    Report Number
    3007566237-2011-04660
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    December 1, 2009
    Report Date
    June 1, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. AT THIS TIME, NO ADDITIONAL INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION REGARDING THE PATIENT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: BROCHARD S, LEMPEREUR M, FILIPETTI P, REMY-NERIS O. CHANGES IN GAIT FOLLOWING CONTINUOUS INTRATHECAL BACLOFEN INFUSION IN AMBULANT CHILDREN AND YOUNG ADULTS WITH CEREBRAL PALSY. DEV NEUROREHABIL. 2009;12(6):397-405. SUMMARY: THE AUTHORS ASSESSED THE EFFECT OF CONTINUOUS INTRATHECAL BACLOFEN INFUSION (ITB) ON GAIT PARAMETERS OF AMBULANT CHILDREN WITH CEREBRAL PALSY (CP). THEY ASSESSED PATIENTS BEFORE AND (B)(6) AFTER INTRATHECAL BACLOFEN (ITB) ON SEVEN CHILDREN WITH CP (MEAN AGE (B)(6)). REPORTABLE EVENT: AFTER IMPLANTATION, ONE PATIENT DEVELOPED A CUTANEOUS HAEMATOMA AND A CATHETER DISCONNECTED REQUIRING FURTHER SURGERY. NO OTHER COMPLICATIONS WERE NOTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention CATHETER: MODEL CATHETER, LOT # UNK| IMPLANTED:| EXPLANTED: