BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3140955 · Received June 3, 2013

    Report

    Report Number
    3007566237-2013-01826
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 2, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8590-1, LOT# N088884, IMPLANTED: (B)(6) 2006, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS OF THE PUMP REVEALED AN EXTERIOR CONCAVE SHIELD WHICH AFFECTED THE POST ¿EXPLANT PUMP PERFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PUMP WAS REMOVED PROPHYLACTIC TO AVOID IN-VIVO BATTERY DEPLETION .DEVICE WAS RETURNED AND ANALYSIS COMPLETED. NO INJURY WAS REPORTED AND PATIENT RECOVERED WITHOUT SEQUELAE. THE PUMP WAS BEING USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245320 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR