BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION PUMP

    MDR report key: 4118260 · Received September 25, 2014

    Report

    Report Number
    3007566237-2014-02698
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Report Date
    September 10, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    BRAITHWAITE, K., ALAZRAKI, A., LOEWEN, J. PICTORIAL REVIEW: COMPLICATIONS OF IMPLANTED SURGICAL DEVICES IN PEDIATRIC PATIENTS. PEDIA TRIC RADIOLOGY. 2014; 44:S206. SUMMARY/REPORTED EVENT: IMPLANTED SURGICAL DEVICES ARE COMMONLY OBSERVED IN PEDIATRIC PATIENTS BY CONVENTIONAL RADIOGRAPHY. THESE DEVICES ARE ROUTINELY ENCOUNTERED IN THE CARE OF PEDIATRIC PATIENTS. COMPLICATIONS ARE SOMETIMES SUSPECTED CLINICALLY, WHILE OTHERS MAY BE DISCOVERED INCIDENTALLY. WHILE SOME COMPLICATIONS ARE MORE SUBTLE, THEY CAN HAVE PROFOUND CLINICAL IMPACT. THE RADIOLOGIST IS OFTEN ASKED TO EVALUATE THESE DEVICES, OR MAY BE THE FIRST TO RECOGNIZE AN IMPORTANT COMPLICATION IN A ROUTINE FILM PERFORMED FOR ANOTHER INDICATION. FAMILIARITY WITH THESE DEVICES AND THEIR POTENTIAL COMPLICATIONS, ALLOWS FOR PROMPT TREATMENT TO AVOID ADVERSE OUTCOME. WE PRESENT A VARIETY OF CASES THAT WE HAVE ENCOUNTERED AT A LARGE CHILDREN¿S HOSPITAL. INCLUDED IN THIS EDUCATIONAL EXHIBIT ARE THE NORMAL AND ABNORMAL RADIOGRAPHIC APPEARANCES OF THESE DEVICES. COMPLICATIONS OF IMPLANTED SURGICAL DEVICES IN PEDIATRIC PATIENTS ARE REVIEWED IN A PICTORIAL FORMAT WITH RELEVANT DISCUSSION. DEVICES INCLUDE BACLOFEN PUMPS. THIS EDUCATIONAL EXHIBIT BETTER FAMILIARIZES THE RADIOLOGIST WITH COMMONLY ENCOUNTERED SURGICAL DEVICES SEEN IN PEDIATRIC PATIENTS BY PRESENTING NUMEROUS EXAMPLES OF MALPOSITIONED OR BROKEN DEVICES. FAMILIARITY WITH THE NORMAL AND ABNORMAL APPEARANCE OF THESE DEVICES ALLOWS FOR PROMPT DIAGNOSIS AND APPROPRIATE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596705 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1