BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202096 · Received July 2, 2013

    Report

    Report Number
    3007566237-2012-01024
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    April 13, 2012
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: CATHETER 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2012 PARTIAL; ACCESSORY 8590-1, LOT# N068190, IMPLANTED: (B)(6) 2006, EXPLANTED: UNK. (B)(4). ANALYSIS OF THE PUMP REVEALED A MOTOR GEAR TRAIN ANOMALY AND CORROSION. ANALYSIS OF THE PARTIAL CATHETER RETURNED REVEALED NO SIGNIFICANT ANOMALY; THE PUMP CONNECTOR HAD DRIED DRUG, BLOOD, OR FOREIGN MATERIAL OCCLUSION.

    Description of Event or Problem · 1

    A CONFIRMED MOTOR STALL WAS NOTED IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. THE PATIENT EXPERIENCED WITHDRAWAL. THE PUMP CONTAINED: FENTANYL 2700 MCG/ML, DILAUDID 20 MG/ML, CLONIDINE 400 MCG/ML, AND BUPIVACAINE 25 MG/ML. PRIOR TO THE MOTOR STALL, AT THE LAST PUMP REFILL ON (B)(6) 2011, THE PUMP WAS PROGRAMMED TO DELIVER FENTANYL 1602 MCG/DAY SIMPLE CONTINUOUS AND 1658 MCG/DAY WITH PTM BOLUSES. THE PATIENT WAS ADMITTED TO THE HOSPITAL APPROXIMATELY ONE WEEK BEFORE THE PUMP WAS REPLACED ON (B)(6) 2012. FOLLOWING THE REPLACEMENT, THE PATIENT RECOVERED AND RECEIVED THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300735 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R