BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2863970 · Received December 10, 2012

    Report

    Report Number
    3007566237-2012-02959
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 9, 2012
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. HCP REPORTED THE PATIENT HAD MENINGITIS AT IMPLANT, FEVER AND INCREASED IN WHITE CELLS COUNT. THE INFECTION WAS IN THE LUMBAR REGION WHERE A CULTURE WAS TAKEN FROM AS WELL AS FROM THE CSF. THE ORGANISM CULTURED WAS UNKNOWN. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS AND THE WHOLE SYSTEM WAS EXPLANTED. IT WAS REPORTED THE INFECTION RESOLVED, THERE WAS NO DRUG WITHDRAWAL BUT OUTCOME YET ONGOING. SYSTEM USED TO DELIVER DILAUDID.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION SHORTLY FOLLOWING PUMP IMPLANT. THE PHYSICIAN WAS TRYING TO DECIDE WHETHER TO LEAVE THE PUMP IN PLACE AND MANAGE THE INFECTION, OR EXPLANT THE SYSTEM. IT WAS REPORTED 11 DAYS LATER THAT THE PATIENT WAS STILL IN THE HOSPITAL DUE TO THE INFECTION. THE PHYSICIAN WAS OUT OF THE COUNTRY AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization