BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2220231 · Received August 16, 2011

    Report

    Report Number
    3007566237-2011-06455
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 22, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A VOLUME DISCREPANCY, THE ACTUAL RESIDUAL VOLUME WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME. AN 18ML WAS ASPIRATED AND 6ML WAS EXPECTED. THE PT WAS NOT GETTING ADEQUATE PAIN RELIEF. AN X-RAY WAS TAKEN AND SHOWED THAT THE PUMP CONNECTOR SLIPPED OFF THE PUMP AND WAS OCCLUDING DRUG FLOW. A REVISION WAS PERFORMED AND THE PUMP CONNECTOR WAS REPLACED. THE PT WAS SUCCESSFULLY RECEIVING DRUG THERAPY FOLLOWING THE REVISION. IT WAS LATER REPORTED THAT THERE WAS A PERSONAL THERAPY MANAGER (PTM) ISSUE PRIOR TO THE REVISION. THE ERROR CODE 0167 WAS DISPLAYING. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS DILAUDID. ADD'L INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N279830008| EXPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG023092N| EXPLANTED:| IMPLANTED: