BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2322553 · Received November 3, 2011

    Report

    Report Number
    3004209178-2011-09042
    Event Type
    Injury
    Date Received
    November 3, 2011
    Report Date
    October 19, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL # 8731SC, SERIAL # (B)(4), IMPLANTED (B)(6) 2009, EXPLANTED UNK; POUCH MODEL # 8590-1, LOT # N180427, IMPLANTED (B)(6) 2009, EXPLANTED UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S PUMP WAS NOT WORKING PROPERLY AND HAD AN X-RAY (DATE UNKNOWN). PER THE REPORTER, THE X-RAY INDICATED THAT THE CATHETER WAS NO LONGER IN THE INTRATHECAL SPACE. THE PATIENT WAS SCHEDULED FOR A CATHETER REVISION SURGERY ON (B)(6) 2011, BUT NEEDED TO FIND A PHYSICIAN TO FILL HIS PUMP. AS OF (B)(6) 2011, THE PATIENT ESTABLISHED NEW MANAGEMENT WITH A NEW PHYSICIAN. NO PATIENT SYMPTOMS WERE REPORTED; THE PATIENT'S STATUS WAS UNDETERMINED AT THE TIME OF THE REPORT. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT A REVISION WAS DONE ON 2011-(B)(6). THE SURGEON FOUND THE CATHETER SPINAL SEGMENT TO BE COMPLETELY OUT OF THE INTRATHECAL SPACE AND A NEW INTRATHECAL SEGMENT WAS PLACED. PUMP WAS INFUSING SALINE SO THAT WAS REPROGRAMMED TO BE INFUSED UNTIL THE PATIENT RETURNED TO HIS NEW MANAGING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention