BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1031199 · Received April 18, 2008

    Report

    Report Number
    6000030-2008-02059
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 18, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED LEG WEAKNESS. A MAGNETIC RESONANCE IMAGING SCAN (MRI) WAS PERFORMED TO RULE OUT INFLAMMATORY MASS. THE MRI CONCLUDED THERE WAS NO INFLAMMATORY MASS. THE PT'S PUMP STALLED AS A RESULT OF THE MRI. A MOTOR STALL RECOVERY MESSAGE WAS NOTED, AND ANOTHER STALL WAS RECORDED. NO RECOVERY WAS NOTED AT THE TIME OF THE REPORT (THE LENGTH OF THE MOTOR STALLS WAS NOT REPORTED). NO ADDITIONAL PT SYMPTOMS, TREATMENT, OR OUTCOME WAS REPORTED. THE DRUG CONTAINED IN THE PT'S PUMP WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8709 N005530303

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXPLANTED:| IMPLANTABLE INFUSION PUMP MODEL 863740| PROGRAMMER MODEL 8840