BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3915213 · Received July 7, 2014

    Report

    Report Number
    3004209178-2014-12566
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE PUMP IMPLANTED WHEN HE WAS (B)(6) AND HE DID NOT WANT TO HAVE IT ANYMORE. THERE WAS NO THERAPY PROBLEM; THE PATIENT JUST DIDN¿T LIKE IT AND IT WAS NOT HIS CHOICE TO HAVE THE IMPLANT INITIALLY. THE PUMP WAS DUE TO REACH EOS (END OF SERVICE) NEXT MONTH ((B)(6) 2014). THE LAST PUMP REFILL WAS (B)(6). THE PUMP WAS ALARMING. TELEMETRY CONFIRMED THE PUMP WAS ALARMING; THE ALARM WAS DUE TO ZERO ML RESERVOIR VOLUME REACHED. THEY TITRATED THE BACLOFEN AND THE PATIENT WAS ON ORAL BACLOFEN. THE PATIENT DID NOT WANT TO HAVE SURGERY TO REMOVE THE PUMP. THE HCP (HEALTH CARE PROVIDER) WAS WONDERING HOW LONG THE PUMP WOULD CONTINUE TO ALARM. THE HCP REQUESTED THE PUMP OFF AUTHORIZATION FORM. THE DEVICE SYSTEM WAS DELIVERING GABLOFEN. IT WAS LATER REPORTED THAT THE PATIENT WISHED TO LEAVE THE EMPTY PUMP IN PLACE. THE PATIENT OUTCOME WAS REPORTED AS ¿RECOVERED WITHOUT PERMANENT IMPAIRMENT¿ AND IT WAS NOTED THAT THE PATIENT WAS ¿DOING WELL AT PRESENT¿.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THEY PLANNED TO PERMANENTLY STOP THE PUMP USING THE PUMP OFF PASSCODE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE HCP WAS SEEING EOS ON (B)(6) 2014 MESSAGE. THE HCP ALSO STATED EMPTY RESERVOIR AND TUBE SET ALARMS HAD GONE OFF. THE PUMP WAS UPDATED TO OFF STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393582 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR