BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2062473 · Received April 12, 2011

    Report

    Report Number
    3007566237-2011-02743
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT HAD AN MRI. THE PUMP WAS INTERROGATED AND FOUND TO BE STALLED. AS OF 2 HOURS AFTER THE MRI, THE PUMP HAD NOT RECOVERED. THE HCP PLANNED TO MANAGE THE PT ACCORDINGLY AND BRING THE PT BACK THE NEXT DAY TO SEE IF THE MOTOR STALL RECOVERED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L 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 40 YR CATHETER: MODEL 8709, LOT# J53362R15| IMPLANTED:| EXPLANTED: