BEUDAMED
    FDA Adverse Event Summary report: N

    UNKNOWN

    MDR report key: 926826 · Received October 11, 2007

    Report

    Report Number
    2182207-2007-03163
    Date Received
    October 11, 2007
    Report Date
    July 20, 2006
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER MANUFACTURER WAS NOT IDENTIFIED. JOURNAL REFERENCE: STINCHON JF, SHAH NP, ET AL. "SCINTIGRAPHIC EVALUATION OF INTRATHECAL INFUSION SYSTEMS: SELECTION OF PATIENTS FOR SURGICAL OR MEDICAL MANAGEMENT." CLINICAL NUCLEAR MEDICINE. 2006; 31(1): 1-4.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: STINCHON JF, SHAH NP, ET AL. "SCINTIGRAPHIC EVALUATION OF INTRATHECAL INFUSION SYSTEMS: SELECTION OF PATIENTS FOR SURGICAL OR MEDICAL MANAGEMENT." CLINICAL NUCLEAR MEDICINE. 2006; 31(1): 1-4. THE ARTICLE DESCRIBES A STUDY USED TO EVALUATE THE UTILITY OF INDIUM 111 DTPA SCINTIGRAPHY IN THE ANALYSIS OF IMPLANTABLE INFUSION SYSTEM MALFUNCTIONS. A TOTAL OF 23 PATIENTS WERE STUDIED WITH 8 INFUSION SYSTEMS EXHIBITING SOME TYPE OF ANOMALY REQUIRING FURTHER INVESTIGATION. SIX OF THE PATIENTS REQUIRED SURGICAL INTERVENTION. REPORTABLE EVENTS: 1. CATHETER OCCLUSION AND BREAK (N=1). 2. CATHETER OCCLUSION AND KINK (N=3). 3. CATHETER LEAK (N=1). 4. CATHETER OCCLUSION (N=1). THE MANUFACTURER OF THE CATHETERS WAS NOT IDENTIFIED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR EXTERNAL PROGRAMMER | IMPLANTABLE INFUSION PUMP| IMPLANTABLE INFUSION PUMP| EXTERNAL PROGRAMMER