BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3072777 · Received April 23, 2013

    Report

    Report Number
    3007566237-2013-01396
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHDRAWAL SYMPTOMS OCCURRED. THE PATIENT EXPERIENCED A SIGNIFICANT INCREASE IN PAIN AND MINOR WITHDRAWAL SYMPTOMS. IT WAS NOTED THE ACTUAL RESIDUAL VOLUME WAS MUCH GREATER THAN THE EXPECTED RESIDUAL VOLUME IN THE DEVICE AT THE PATIENT'S RECENT REFILL. IT WAS NOTED THE HEALTH CARE PROVIDER (HCP) WAS WEANING THE PATIENT OFF ALL MEDICATIONS, PLANNED TO PUT WATER IN THE PUMP. THE HCP BELIEVED THE CATHETER WAS "FAILING" AND WAS PRETTY SURE IT WAS OCCLUDED OR KINKED AT THE VERY LEAST. IT WAS NOTED THE HCP ALSO BELIEVED IT HAD BEEN FAILING FOR ABOUT SIX TO SEVEN MONTHS. IT WAS REPORTED THERE WAS NOTHING IN THE PUMP LOGS OUT OF THE ORDINARY. THE HCP WAS GOING TO MICRODOSE THE PATIENT ON MORPHINE AND PERFORM A CATHETER ACCESS PORT STUDY TO EVALUATE THE CATHETER. IT WAS THOUGHT TO THE REPORTER THAT THE PATIENT HAD EXPERIENCED THE SYMPTOMS FOR THE PAST TWO MONTHS. IT WAS UNKNOWN TO THE REPORTER WHAT MEDICATIONS WERE BEING ADMINISTERED VIA THE DEVICE SYSTEM BUT REPORTED THE PATIENT'S PREVIOUS HCP HAD THE PATIENT ON "SOME BIG CONCOCTION." ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD NOT BEEN SCHEDULED FOR A REVISION AS FAR AS THE REPORTER KNEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174781 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1