BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2990511 · Received March 5, 2013

    Report

    Report Number
    3007566237-2013-00684
    Event Type
    Injury
    Date Received
    March 5, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# J11973R17, IMPLANTED: (B)(6) 2004. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HIS PUMP EXPLANTED DUE TO BACTERIAL, SPINAL MENINGITIS. IT WAS UNKNOWN IF THE PUMP WAS RELATED TO THE MENINGITIS. AFTER THE EVENT RESOLVED, A NEW PUMP WAS IMPLANTED. THE DRUGS USED IN THE SYSTEM WERE FENTANYL, BUPIVACAINE, DROPERIDOL, BACLOFEN, AND DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93089 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R