BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1002338 · Received February 22, 2008

    Report

    Report Number
    6000030-2008-00884
    Event Type
    Injury
    Date Received
    February 22, 2008
    Report Date
    January 24, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED THAT ON 2 DIFFERENT OCCASIONS HE FELT HE WAS GOING THROUGH WITHDRAWAL. HE REPORTED FEELING NERVOUS AND JERKING, AS WELL AS, WEAKNESS AND DIFFICULTY STANDING. THE FIRST OCCASION LASTED 3 DAYS AND THE SECOND OCCASION HAPPENED ABOUT 2 WEEKS AGO AND LASTED ABOUT 2-3 DAYS. THE PT ALSO REPORTED THAT A COUPLE OF MONTHS AGO AT A REFILL VISIT, HE OVER HEARD "THAT'S A WHOLE LOT OF MEDICATIONS LEFT". HE DID NOT KNOW THE AMOUNTS. HE INCLUDED THAT THE HCP HAD DONE AN MRI (DATE NOT REPORTED) AND CONFIRMED THAT HE DID NOT HAVE A GRANULOMA. THE PUMP WAS USED TO DELIVER DILAUDID. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8709 J10952R16

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT # UNK| IMPLANTED| EXPLANTED| IMPLANTED| PUMP MODEL 8627-18