BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1022843 · Received March 28, 2008

    Report

    Report Number
    2182207-2008-01620
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 22, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S PUMP WAS REPLACED. DURING THE PUMP REPLACEMENT, IT WAS DETERMINED THAT THE PT'S CATHETER WAS BROKEN THE L2-L3 LEVEL. THE CATHETER WAS REVISED. NO PT SYMPTOMS WERE REPORTED. THE DRUG CONTAINED IN THE PT'S PUMP WAS NOT REPORTED. SEE MFR REPORT #2182207200801619.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK MEDTRONIC NEUROMODULATION CATHETER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| EXPLANTED| EXPLANTED| IMPLANTED| IMPLANTABLE INFUSION PUMP MODEL PUMP LOT#UNK| PROGRAMMER MODEL PROGRAMMER LOT#UNK