BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2220232 · Received August 16, 2011

    Report

    Report Number
    3007566237-2011-06442
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 22, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S CATHETER WAS FRACTURED. THE PT'S MEDICATION WAS INCREASED FREQUENTLY. WHEN THE PT'S PUMP WAS REPLACED. THE CATHETER WAS FRACTURED AND IT WAS REPLACED AT THE SAME TIME THE PUMP WAS. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8731, LOT# B005645N03| EXPLANTED: