BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2834085 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10320
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    June 1, 2009
    Report Date
    October 16, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT INFORMED THE CLINIC THAT THE PUMP "HAS TO BE REMOVED DUE TO RECALL." THE PATIENT AND HIS LAWYER FELT THAT THE PUMP AND CATHETER HAD BEEN RECALLED. THE PATIENT REPORTED A BURNING SENSATION AT THE CATHETER BUT DID NOT HAVE FURTHER INFORMATION ON THE LOCATION OF THE BURNING. IT WAS REPORTED THAT THE PATIENT WAS SUSPECTED TO HAVE DEVELOPED AN INFLAMMATORY MASS BECAUSE HE HAD A BURNING SENSATION AT THE CATHETER SITE FOR ABOUT A YEAR AND HAD A MASS AT THE SITE. THE PATIENT HAD URINARY RETENTION AND "HE SLEEPS FOR DAYS." THE REPORTER STATED THAT EVER SINCE THE PATIENT'S LAST PUMP REPLACEMENT, THE PATIENT HAD NO HAD PAIN RELIEF. THE PATIENT WAS ON BACLOFEN FOR ABOUT 3 MONTHS BEFORE THE HEALTHCARE PROVIDER (HCP) CHANGED HIS MEDICATION TO MORPHINE. THE PATIENT HAD BEEN TAKING ORAL BACLOFEN. THE REPORTER DID NOT THINK THAT THE HCP HAD ORDERED ANY TESTS TO CHECK THE PUMP. PATIENT OUTCOME WAS UNKNOWN. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE AND BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other