BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202390 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01020
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    March 13, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), EXPLANTED: 2009-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NERVE IRRITATION AFTER THE SECOND PUMP WAS PLACED AT THE SAME POCKET AS THE FIRST ONE. THE PUMP WAS MOVED TO THE RIGHT SIDE AFTER MONTHS. THE PATIENT STATED ONLY GOT 10 PERCENT PAIN RELIEF. THE PATIENT HAD MORPHINE AND BACLOFEN IN THE PUMP. THE PATIENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301970 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention