BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3222360 · Received July 12, 2013

    Report

    Report Number
    3007566237-2013-02320
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD THEIR PUMP EXPLANTED DUE TO AN INFECTION. THERE WAS NO ADDITIONAL INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321805 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention