BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2093621 · Received May 12, 2011

    Report

    Report Number
    3007566237-2011-03458
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 20, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    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 THE PT EXPERIENCED A BURNING SENSATION, TUGGING, AND VIBRATION FROM THE PUMP WHEN THE PT HAD AN MRI. THE MRI TECH STOPPED THE MRI AFTER THE PT REPORTED THE SYMPTOMS. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS NOT KNOWN. ADDITIONAL INFO HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 39 YR IMPLANTED:| CATHETER: MODEL 8709SC, LOT # N217535013| EXPLANTED: