BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOMED NON-PROGRAMMABLE PUMP

    MDR report key: 1890189 · Received October 22, 2010

    Report

    Report Number
    3007566237-2010-08254
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    February 1, 2010
    Report Date
    September 16, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P990034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED AN INCREASE IN BASELINE PAIN SINCE (B)(6) 2010. A VOLUME DISCREPANCY WAS REPORTED. IT WAS STATED THE PUMP'S FLOW RATE HAS BEEN DECREASING FROM AN AVERAGE 0.41MLS/DAY TO APPROXIMATELY 0.25 ML/D. A DYE CATHETER STUDY SHOWED NORMAL CATHETER FLOW AND NO APPARENT BLOCKAGES. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 IMPLANTED:| CATHETER: MODEL CATHETER, LOT # UNK| EXPLANTED: