BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3070896 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06643
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 26, 2013
    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
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: CATHETER: PRODUCT ID 8596, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MISSED A PUMP REFILL. THE PATIENT DID NOT GO IN FOR THE REFILL UNTIL HIS ALARM STARTED BEEPING. THE ALARM HAD BEEN ACTIVE FOR 2 DAYS. THE REPORTER STATED THAT THE PATIENT HAD JUST ARRIVED AT THE OFFICE AND THE PUMP WAS EMPTY. THE EMPTY RESERVOIR ALARM OCCURRED 2 DAYS PRIOR TO THE REPORT, ON (B)(6) 2013. THE PATIENT EXPERIENCED HEADACHE AS A RESULT OF THE EVENT. THE DEVICE SYSTEM WAS USED TO DELIVER COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171595 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1