BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201477 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00014
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    October 21, 2011
    Report Date
    February 20, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: 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 THE PATIENT WENT THROUGH WITHDRAWAL WHEN THEIR PUMP HAD NORMAL BATTERY DEPLETION ON (B)(6) 2012. THE PUMP WAS REPLACED 3 DAYS LATER AND THE PATIENT RECOVERED WITHOUT SEQUELA. IT WAS NOTICED AT A REFILL ON (B)(6) 2012 THAT THE PUMP WAS DISPLAYING ELECTIVE REPLACEMENT INDICATOR (ERI) OCCURRED ON (B)(6) 2011. THE PUMP WOULD REACH END OF SERVICE (EOS) ON (B)(6) 2012. THE PATIENT WAS HOSPITALIZED DUE TO THE EVENT. THE DRUG DEVICE SYSTEM WAS USED TO DELIVER MORPHINE AND MARCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303123 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R