BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2061950 · Received April 5, 2011

    Report

    Report Number
    3004209178-2011-02619
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 27, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SEROMA. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM AND REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2011. IT WAS DETERMINED THAT THE CATHETER WAS "NOT IN IT (INTRATHECAL) SPACE." THE HCP PLANNED TO STOP THE PUMP FOR SURGERY. THE PATIENT HAD NOT BEEN RECEIVING ITB (INTRATHECAL BACLOFEN THERAPY) DUE TO THE CATHETER MALPOSITION. THE PATIENT'S CONDITION WAS REPORTED AS STABLE; THE HCP "WAS MANAGING ANY WITHDRAWAL ISSUES." ADDITIONAL INFORMATION HAS BEEN REQUESTED, 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 II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR CATHETER: MODEL 8596SC, LOT# N280406009| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8598A, LOT# N280288001