BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3973896 · Received August 1, 2014

    Report

    Report Number
    3007566237-2014-02162
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1579-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8590-1, LOT# N180427, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709, LOT# L80325, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: CATHETER. PRODUCT ID: 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED A FEEDTHRU ANOMALY OF THE MOTOR, WHICH WAS SPECIFIED AS SHORTING ACROSS THE INSULATOR.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION. THERE WAS A CRITICAL ALARM. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED OR REQUIRED. THE PATIENT EXPERIENCED INCREASED SPASTICITY. THE CAUSE OF THE PRODUCT ISSUE WAS NOT DETERMINED. THE SYSTEM WAS BEING USED TO DELIVER BACLOFEN. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ¿ALIVE- NO INJURY.¿

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT, AFTER THE PUMP WAS REPLACED, THE ISSUE WAS CONSIDERED TO BE RESOLVED. ADDITIONAL INFORMATION, INCLUDING PATIENT OUTCOME AND THE CAUSE OF THE EVENT, WAS NOT REPORTED, HOWEVER ADDITIONAL FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451106 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention