BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3172139 · Received June 17, 2013

    Report

    Report Number
    3007566237-2013-01993
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    November 8, 2012
    Report Date
    May 23, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION AT THE INCISION SITE. THE PATIENT HAD A RED RASH AT THE INCISION SITE AND A LOW GRADE TEMPERATURE. THE PUMP AND CATHETER WERE EXPLANTED. THE SEVERITY OF THE EVENT WAS NOTED TO BE ¿MODERATE¿. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272768 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention