BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1021621 · Received March 26, 2008

    Report

    Report Number
    6000030-2008-01572
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Report Date
    February 25, 2008
    Manufacturer
    RICE CREEK MFG.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONNECTOR WAS BROKEN AND SURGICALLY REPLACED. NO PT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MFG. 8709 J0177989R

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED| IMPLANTED| IMPLANTABLE INFUSION PUMP MODEL 863740| EXPLANTED| PROGRAMMER MODEL 8840 LOT #UNK| IMPLANTED| LOT # NGV409697H