BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N'VISION

    MDR report key: 1022588 · Received April 1, 2008

    Report

    Report Number
    2182207-2008-01719
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 2, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S BACLOFEN RATE WAS REPROGRAMMED TO 751.3 MCG/DAY IN 2008. BY NOON OF THE NEXT DAY, THE PT WAS HAVING SOME ABNORMAL MOTOR BEHAVIORS; LATER THAT DAY, HE BEGAN EXPERIENCING FULL BLOWN SPASMS, A HEART RATE OF 180 BEATS PER MINUTE AND HIGH BLOOD PRESSURE (READING NOT PROVIDED). THE PT DID NOT HAVE A FEVER. THE DEVICE WAS REVIEWED ON 03/02/2008 AND FOUND TO BE IN STOPPED PUMP MODE. THE PUMP LOGS OF ORIGINAL DATE WERE REVIEWED WITH TECHNICAL SERVICES, AND IT APPEARED TELEMETRY WAS INTERRUPTED. THE HCP WAS GOING TO REPROGRAM THE PT BACK TO HIS REGULAR DOSING. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N'VISION LKK MEDTRONIC NEUROMODULATION 8840 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention EXPLANTED| IMPLANTED| EXPLANTED| IMPLANTED| PUMP MODEL # 863720| CATHETER MODEL 8709 LOT # N136044007