BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOMED NON-PROGRAMMABLE PUMP

    MDR report key: 2143029 · Received June 23, 2011

    Report

    Report Number
    3007566237-2011-04700
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P990034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE LAST REFILL, THE HEALTHCARE PROVIDER THOUGHT THAT THE SEPTUM WAS LEAKING. THE PUMP WAS FILLED WITH SALINE AND IT WAS DETERMINED THAT IT WAS LEAKING INTO THE POCKET. NO DYE STUDY WAS PERFORMED. THE PUMP WAS REPLACED. THERE WAS NO PT INJURY AND THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOMED NON-PROGRAMMABLE PUMP LKK MEDTRONIC NEUROMODULATION 8472 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention