BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3896963 · Received June 26, 2014

    Report

    Report Number
    3004209178-2014-12088
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    February 19, 2014
    Report Date
    June 19, 2014
    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
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: CATHETER; PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT WAS SEEN IN HER HOME BY A HOME HEALTH NURSE FOR AN INTRATHECAL PUMP REFILL VISIT AND ASSESSMENT. THE PATIENT PAIN WAS SLIGHTLY WORSENED SINCE THE LAST HOME REFILL VISIT. IT WAS NOTED THAT THE PATIENT STAYED IN BED MOSTLY ON A DAILY BASIS DUE TO HER CHRONIC FATIGUE, PAIN, AND WEAKNESS. THE PATIENT WAS CONTINUING TO HAVE DIFFICULTY WITH HER ACTIVITIES OF DAILY LIVING DUE TO HER PAIN THRESHOLD. THE PATIENT USED A WALKER TO AMBULATE. THE PATIENT¿S DAUGHTER ASSISTED THE PATIENT LARGELY WITH DAILY ACTIVITIES. THE PATIENT RECEIVED WEEKLY LOWER LEFT EXTREMITY WOUND TREATMENTS AT THE WOUND CLINIC. THE PATIENT WAS SEEN AGAIN IN HER HOME ON (B)(6) 2014 FOR INTRATHECAL PUMP REFILL AND A NURSING ASSESSMENT. AT THAT VISIT, IT WAS NOTED THAT THE PATIENT AMBULATED WITH A ROLLING WALKER AND EXPERIENCED CHRONIC FATIGUE, PAIN, AND WEAKNESS. THE PATIENT CONTINUED TO HAVE DIFFICULTY WITH HER ACTIVITIES OF DAILY LIVING DUE TO HER PAIN THRESHOLD. THE PATIENT HAD A RECENT FOOT SURGERY ON (B)(6) 2014 TO CORRECT ABNORMALITIES. THE PATIENT HAD CHRONIC FOOT AND LEG ULCERATIONS. IT WAS ALSO NOTED THAT THE PUMP HAD SUCCESSFULLY RECOVERED POST MRI MOTOR STALL. THE DRUG BEING DELIVERED VIA THE DEVICE SYSTEM AT THE TIME OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375015 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR