BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1832261 · Received September 3, 2010

    Report

    Report Number
    3007566237-2010-06755
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 6, 2010
    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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE GUIDE WIRE WAS SHORTER THAN THE CATHETER. THE DISCREPANCY WAS NOTICED BEFORE THE GUIDE WIRE WAS REMOVED. PHYSICIAN STILL IMPLANTED ONE CATHETER, BUT DID NOT IMPLANT THE OTHER. IT WAS NOTED THAT THERE WERE TWO CATHETER GUIDE WIRES THAT WERE ABOUT 5MMS SHORTER THAN THE CATHETER AND HAD SOME TROUBLE WITH ADVANCEMENT. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED WHEN AVAILABLE. REFER TO MANUFACTURER REPORT #: 3007566237-2010-06753.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1