BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3123473 · Received May 22, 2013

    Report

    Report Number
    3007566237-2013-01699
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 8 590-1, LOT# N0041525, IMPLANTED: (B)(6) 2005, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT¿S PUMP WAS REPLACED LAST YEAR. THE CATHETER WAS ¿FRAGMENTED¿ AND AT THAT TIME IT WAS OPTED NOT TO FIX THE FRAGMENTED CATHETER. IT WAS THOUGHT THAT THIS WOULD NOT BE REPAIRED AT THE TIME OF THIS REPORT AS THE PATIENT CURRENTLY HAD AN ANEURISM AND ¿A LOT OF MEDICAL PROBLEMS.¿ IT WAS REPORTED THAT THE PATIENT WAS GETTING RELIEF LAST YEAR, BUT PERHAPS THE MEDICATION WAS NOT IN THE RIGHT PLACE. IT WAS UNKNOWN WHAT MEDICATION THIS DEVICE SYSTEM DELIVERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225911 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR