BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1864476 · Received October 6, 2010

    Report

    Report Number
    3007566237-2010-07670
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    January 1, 2007
    Report Date
    September 9, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT NEVER HAD THERAPEUTIC EFFECT OR EFFECTIVE PAIN RELIEF. THE PT BEGAN TO EXPERIENCE "SEVERE WITHDRAWAL SYMPTOMS" A FEW WEEKS PRIOR TO THIS REPORT. A CT SCAN, WITH CONTRAST, WAS PERFORMED AND IT WAS DETERMINED THAT THE PT'S CATHETER WAS FRACTURED. THE PT'S PUMP WAS MOVED AND THE CATHETER WAS REPLACED. THE PT'S PUMP CONTAINED MORPHINE AND WAS DECREASED "FROM 9 TO 5". THE CONCENTRATION AND DOSAGE OF MORPHINE USED IN THE PT'S PUMP, AT THE TIME OF THIS REPORT, WERE UNCLEAR. THE PT THEN REPORTED GREATER PAIN RELIEF. IT WAS STATED THAT THE PT'S PHYSICIANS WERE IN THE PROCESS OF ADJUSTING THE MORPHINE DOSAGE. IT WAS SUSPECTED THAT THE PT'S CATHETER MAY HAVE BEEN FRACTURED SINCE THE TIME OF IMPLANTATION. NO FURTHER DETAILS OR PT OUTCOME WERE PROVIDED. ADD'L INFO WAS REQUESTED BUT NOT REC'D AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N121689002