BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 5345201 · Received January 5, 2016

    Report

    Report Number
    3007566237-2016-00036
    Event Type
    Injury
    Date Received
    January 5, 2016
    Report Date
    December 12, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    SCANLON, M., BENDEL,M.A., GAZELKA,H.M., HOELZER,B., HOOTEN, M., MOESCHLER,S., LAMER,T.J. SURGICAL SITE INFECTIONS IN CANCER PATIENTS WITH INTRATHECAL DRUG DELIVERY (10272). (B)(6). 2015. 74. SUMMARY: INTRATHECAL DRUG DELIVERY SYSTEMS (IDDS) ARE IMPLANTED IN CANCER PATIENTS PRIMARILY FOR INTRACTABLE PAIN THAT IS REFRACTORY TO MEDICAL MANAGEMENT. CANCER PAIN HAS BEEN SHOWN TO BE SIGNIFICANTLY IMPROVED BY IDDS COMPARED TO MEDICAL THERAPY (REF: SMITH ET AL. ANNALS OF ONCOLOGY 16: 825-833, 2005). THE REPORTED INCIDENCE OF INFECTIOUS COMPLICATIONS FOLLOWING IDDS PLACEMENT VARIES FROM 2 - 8% AND FREQUENTLY REQUIRES PROLONGED ANTIBIOTICS AND DEVICE REMOVAL (REF: ENGLE ET AL. PAIN PHYSICIAN 16: 251-257, 2013). THERE IS LIMITED DATA TO DESCRIBE THE INCIDENCE OF SURGICAL SITE INFECTIONS (SSI) INVOLVING INTRATHECAL PUMP PLACEMENT IN IMMUNOCOMPROMISED CANCER PATIENTS. REPORTED EVENTS: SIXTY-FOUR PATIENTS WERE IDENTIFIED WHO HAD INTRATHECAL PUMPS IMPLANTED BETWEEN THE YEARS 2006 AND 2013. THERE WERE 5 (7.8%) PATIENTS WHO DEVELOPED SURGICAL SITE INFECTIONS. ALL FIVE OF THESE PATIENTS HAD RECEIVED CHEMOTHERAPY OR RADIATION WITHIN 2 MONTHS OF IMPLANTATION. FOUR OF THE 5 WERE ON DEXAMETHASONE. TWO PATIENTS ALSO HAD CONCOMITANT INFECTIONS AT TIME OF IDDS PLACEMENT. FOUR OF THE 5 PATIENTS REQUIRED EXPLANTATION OF THE INTRATHECAL DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4724 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention