BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDRA

    MDR report key: 1022238 · Received March 26, 2008

    Report

    Report Number
    2182207-2008-01619
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S PUMP WAS REPLACED AND THE CATHETER REVISED AND REPLACED WITH A SUTURELESS CONNECTOR. A WEEK AFTER REPLACEMENT, IT WAS FOUND THAT THE CATHETER WAS DISCONNECTED FROM THE PUMP. THE CATHETER WAS REPLACED. THE PT RECOVERED WITHOUT SEQUELA AND IS DOING WELL. THE DRUG CONTAINED IN THE PT'S PUMP WAS NOT REPORTED. NO PT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDRA LKK MEDTRONIC NEUROMODULATION 8709SC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL PROGRAMMER| EXPLANTED:| IMPLANTED:| IMPLANTABLE INFUSION PUMP MODEL PUMP