BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 3151533 · Received June 7, 2013

    Report

    Report Number
    3007566237-2013-01884
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0591-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: CATHETER MODEL/SERIAL#: UNK, IMPLANTED/ EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN MRI THE PUMP HAD STALLED AND IT NEVER RESTARTED. PER REPORTER THIS WAS A LONG TIME AGO. NO FURTHER INFORMATION WAS AVAILABLE ABOUT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252200 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1