BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 1012466 · Received March 12, 2008

    Report

    Report Number
    2182207-2008-01211
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    January 1, 2006
    Report Date
    October 18, 2006
    Manufacturer
    NEUROLOGICAL DIVISION, MEDTRONIC, INC.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR STALL MESSAGE WAS NOTED UPON INTERROGATION POST MRI. NO OTHER INFO WAS PROVIDED IN RELATIONSHIP TO TIME PUMP HAD STALLED, RECOVERY OR RETURN OF PT SYMPTOMS. PT IDENTIFIERS WERE NOT PROVIDED; FURTHER FOLLOW-UP IS NOT POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK NEUROLOGICAL DIVISION, MEDTRONIC, INC. PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| CATHETER MODEL CATHETER LOT# UNK