BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2212633 · Received August 11, 2011

    Report

    Report Number
    3007566237-2011-06275
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 21, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED WITHDRAWAL. THE PATIENT SYMPTOMS WERE VOMITING AND DIARRHEA, TROUBLE FOCUSING. THE DRUGS USED IN THE PUMP AT THE TIME OF THE EVENT WERE FENTANYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT # J12116R24| CATHETER: MODEL 8711, LOT # N084114034