BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3203613 · Received July 3, 2013

    Report

    Report Number
    3007566237-2013-02201
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    May 1, 2013
    Report Date
    March 23, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO A HEALTHCARE PROVIDER (HCP) WHO HAD NOT MANAGED A PAIN PUMP AS THE PATIENT WAS NO LONGER SEEING THE MANAGING PHYSICIAN. THE HCP STATED THAT THE PATIENT WAS ¿NOT SURE THAT IT¿S QUITE WORKING¿. THE PATIENT TOLD THE HCP THAT THE BATTERY WAS SUPPOSED TO BE RUNNING OUT BUT WAS NOT SURE IF IT WAS STILL WORKING. THE HCP WAS TRYING TO DECIDE WHETHER OR NOT TO KEEP THE PUMP IMPLANTED AND WHETHER OR NOT THE PUMP WAS ¿DOING ANYTHING¿. THE PATIENT FELT LIKE HE USED THE PUMP AND IT ¿DOESN¿T DO ANYTHING ANYMORE¿. THE HCP WAS UNSURE IF THE PUMP WAS NOT WORKING OR IF THE PATIENT HAD DEVELOPED A TOLERANCE TO THE MEDICATION. THE HCP THOUGHT THE ISSUE HAD BEEN OCCURRING FOR SEVERAL WEEKS. THE DEVICE SYSTEM DELIVERED DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A CONSUMER REPORTED THE PATIENT'S PUMP HAD FAILED RESULTING IN WITHDRAWAL, PAIN, SPASTICITY, HOSPITALIZED, AND SURGERY TO REPLACE THE PUMP ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305073 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention