BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3113830 · Received May 15, 2013

    Report

    Report Number
    3007566237-2013-01623
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709, LOT# J11328R37, IMPLANTED: (B)(6) 2002, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT AT HIS LAST PUMP REFILL ON (B)(6) 2013 THERE WERE 17 ML¿S LEFT IN THE PUMP, AND THERE SHOULD HAVE ONLY BEEN ¿LIKE TWO TO FIVE¿. THIS WAS NOTED TO HAVE BEEN OUT OF SPECIFICATION. THE PATIENT STATED THAT HE HAD BEEN IN A LOT MORE PAIN AND WAS HAVING PAIN. THE MEDICATIONS USED WITHIN THE SYSTEM WERE DILAUDID, BACLOFEN, AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214360 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1