BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2840999 · Received November 20, 2012

    Report

    Report Number
    3007566237-2012-02797
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    February 28, 2010
    Report Date
    October 24, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, LOT#: J11160R60, IMPLANTED: (B)(6) 2002, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS IMPLANTED AFTER ITS USE BEFORE DATE (UBD). IT WAS INDICATED THAT THE DAYS EXPIRED AT IMPLANT WAS 215 DAYS. THERE WERE NO PATIENT SYMPTOMS REPORTED. THE DRUG DELIVERED VIA PUMP WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR