BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3269625 · Received August 7, 2013

    Report

    Report Number
    3007566237-2013-02619
    Event Type
    Injury
    Date Received
    August 7, 2013
    Date of Event
    July 14, 2013
    Report Date
    July 22, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: CATHETER: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: CATHETER: PRODUCT ID 8590-1, LOT# N113866, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALARM OCCURRED. THE PATIENT STARTED HEARING THE ALARM ON (B)(6) 2013. A POSSIBLE MOTOR STALL WAS DISCUSSED. THE DEVICE SYSTEM WAS USED TO DELIVER BUPIVACAINE 5MG/ML AND DILAUDID 50MG/ML AT 11.14 MG/DAY. IT WAS LATER REPORTED THAT THE PUMP WAS REPLACED. THE ALARM WAS DUE TO A MOTOR STALL. THE PUMP LOGS REVEALED THAT A MOTOR STALL OCCURRED ON (B)(6) 2013. THE PATIENT STATUS ON THE DAY OF THE REPLACEMENT WAS REPORTED AS ¿ALIVE-NO INJURY¿. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370798 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention