BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2896925 · Received January 4, 2013

    Report

    Report Number
    3007566237-2013-00034
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Report Date
    December 7, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A VOLUME DISCREPANCY WAS REPORTED. ACTUAL RESIDUAL VOLUME WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME AT THE LAST 2 REFILLS. IT WAS INDICATED THAT THE PUMP NOW CONTAINED SALINE BUT PREVIOUSLY HAD FENTANYL, CLONIDINE AND BUPIVACAINE. PER THE REPORTER OVER THE LAST 9 MONTHS THE PATIENT HAD BEEN BETTER THAN HE HAS EVER BEEN. THE PATIENT IS ALSO SEEKING A CLOSER HCP AS THE PREVIOUS HCP "DISMISSED" THE PATIENT DUE TO DISTANCE; PATIENT HAD BEEN FLYING BACK TO UT FOR PUMP REFILLS. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE TO US

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4655 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1