BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1850880 · Received September 28, 2010

    Report

    Report Number
    3007566237-2010-07386
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    March 5, 2007
    Report Date
    June 11, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED AN INCREASE IN PAIN. THE PT'S HEALTH CARE PROVIDER "THOUGHT" THE PT'S SYMPTOMS MAY HAVE BEEN DUE TO A KINK OR OCCLUSION IN THE CATHETER, BUT NO PROBLEM WITH THE CATHETER WAS NOTED. THE PT'S CATHETER WAS MOVED DOWN FROM T4 TO T10. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE MORPHINE SULFATE, BUPIVICAINE, AND COMPOUNDED BACLOFEN. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8709AA, LOT# N058476024| IMPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNK