BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2081055 · Received April 14, 2011

    Report

    Report Number
    3007566237-2011-02810
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    MEDTORNIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY WERE UNABLE TO ASPIRATE FROM A PT'S CATHETER. THE PROBLEM WAS CONFIRMED BY A DYE STUDY. A (B)(4) STUDY WAS DISCUSSED. NO FURTHER INFORMATION WAS REPORTED AT THIS TIME, INCLUDING THE DRUG/COMPOUND BEING DELIVERED VIA THE PUMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTORNIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| CATHETER: MODEL CATHETER, LOT# UNK| IMPLANTED: