BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2180947 · Received July 22, 2011

    Report

    Report Number
    3007566237-2011-05683
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 5, 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 HAD THEIR SYSTEM REPLACED AND IT TURNED OUT THAT THERE WAS A FRACTURED CATHETER AND THE CATHETER WAS NOT CONNECTED TO THE PUMP. AS A RESULT OF THE ISSUE, THE PT HAD TO HAVE A "BIT MORE OF A SURGERY" AND HAD TO BE ADMITTED TO ICU OVERNIGHT. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL 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 Hospitalization| R EXPLANTED:| CATHETER: MODEL 8731, LOT# B005645N03| IMPLANTED: