BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1230005 · Received November 12, 2008

    Report

    Report Number
    6000030-2008-07399
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 13, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A WOUND DEHISCENCE AT THE PUMP SITE. THE PATIENT EXPERIENCED INCREASED SPASTICITY AND DIAPHORESIS. THE PATIENT WAS IN THE INTENSIVE CARE UNIT AND THE PHYSICIAN WAS CONSIDERING AGGRESSIVE WEANING OF INTRATHECAL BACLOFEN AND PUMP REMOVAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER| CATHETER: MODEL 8703W| IMPLANTED: