BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4525392 · Received February 18, 2015

    Report

    Report Number
    3004209178-2015-03258
    Event Type
    Malfunction
    Date Received
    February 18, 2015
    Date of Event
    January 27, 2015
    Report Date
    January 27, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE HEALTHCARE PROFESSIONAL (HCP) INTERROGATED THE PATIENT'S PUMP TO DO A REFILL AND SAW THE PUMP WAS IN SAFE STATE. THE PUMP LOGS WERE READ AND INDICATED A BATTERY FAILURE. A LOW BATTERY RESET OCCURRED. THE SAFE STATE DID NOT OCCUR WHILE UPDATING THE PUMP NOR WAS FLEX BOLUS IN USE. THERE WAS NO ELECTROMAGNETIC INTERFERENCE OR MAGNETIC RESONANCE IMAGING (MRI) ASSOCIATED TO THE SAFE RATE. NO OTHER TROUBLESHOOTING, INTERVENTIONS OR OTHER ACTIONS WERE TAKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED AND THE PATIENT'S CAREGIVER REPORTED NO OBVIOUS CHANGE IN SPASTICITY. THE PATIENT WAS REPORTED TO HAVE RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE PUMP WAS USED TO DELIVER GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115857 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00013 YR