BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 3394388 · Received October 8, 2013

    Report

    Report Number
    3007566237-2013-03287
    Event Type
    Injury
    Date Received
    October 8, 2013
    Date of Event
    January 1, 2012
    Report Date
    September 19, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE EVENT DATE WAS NOT PROVIDED; THE DATE IS BASED ON DATE OF PUBLICATION OF THE LITERATURE ARTICLE. THE DATE IS AN ESTIMATE AS ONLY THE YEAR OF PUBLICATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR INDICATED THAT THE DEVICE WAS MANUFACTURED BY MEDTRONIC AND MEDTRONIC ALSO PROVIDED SOME OF THE ALLERGY TEST MATERIALS. SPECIFIC DEVICE INFORMATION WAS NOT KNOWN BY THE AUTHOR.

    Description of Event or Problem · 1

    BROEKAERT, S. M., BREHLER, R., METZE, D. POST-IMPLANTATION ERYTHEMA. JOURNAL DER DEUTSCHEN DERMATOLOGISCHEN GESELLSCHAFT = JOURNAL OF THE GERMAN SOCIETY OF DERMATOLOGY : JDDG. 2012;10(11):839-841. DOI: 10.1111/J.1610-0387.2012.08026.X. SUMMARY: POST-IMPLANTATION ERYTHEMA (PIE) IS A LOCAL SKIN REACTION TO THE IMPLANTATION OF PACEMAKERS, PAIN PUMPS, AND JOINT PROSTHESES. THE CLINICAL APPEARANCE CONSISTS OF ERYTHEMA WITHOUT WARMTH OR TENDERNESS. HISTOLOGY SHOWS DILATION ¿ AND SOMETIMES PROLIFERATION ¿ OF BLOOD AND LYMPH VESSELS, AND SOMETIMES A MORE OR LESS PRONOUNCED INFLAMMATORY INFILTRATE. THE DISEASE PATHOGENESIS REMAINS UNCLEAR AND ITS COURSE VARIES; SPONTANEOUS REGRESSION CAN OCCUR. PIE IS AN IMPORTANT DIFFERENTIAL DIAGNOSIS IN PATIENTS WITH SUSPECTED INFECTION OR CONTACT ALLERGY AND SHOULD BE RULED OUT. IN THE FOLLOWING, WE PRESENT THE CLINICAL AND HISTOLOGICAL SPECTRUM OF PIE AND DISCUSS THE DIFFERENTIAL DIAGNOSES BASED ON TWO OF OUR OWN PATIENTS. REPORTED EVENT: A (B)(6) MAN CAME TO OUR DEPARTMENT ONE WEEK AFTER IMPLANTATION OF A PAIN PUMP WITH HORSESHOE-SHAPED REDNESS AND ITCHING ON THE LOWER LEFT ABDOMEN. HISTOLOGICAL EXAMINATION SHOWED IRREGULAR THICKENING OF THE EPIDERMIS AND ORTHOKERATOSIS. THE UPPER DERMIS CONTAINED TELANGIECTASES AND SLIGHTLY DILATED LYMPH VESSELS AS WELL AS DISCRETE FIBROSIS. A SPARSE INFLAMMATORY LYMPHOCYTIC INFILTRATE WITH SOLITARY NEUTROPHILS AND EOSINOPHILS WAS FOUND SURROUNDING THE VESSELS. MICROBIOLOGY AND MYCOLOGICAL TESTS DID NOT REVEAL BACTERIAL OR FUNGAL GROWTH FROM THE PAIN CATHETER TIP. PATCH TEST READINGS AT 48 AND 72 HOURS WERE NEGATIVE FOR TYPE IV SENSITIZATION TO DISINFECTANTS, RUBBER, DENTAL METALS, PROSTHESIS MATERIALS (DKG TEST SERIES), AND OTHER INDIVIDUAL SUBSTANCES IN CONTACT WITH THE TISSUE. A NEW PAIN PUMP MADE BY A DIFFERENT MANUFACTURER HAD TO BE IMPLANTED AFTER FIVE MONTHS DUE TO PERSISTENT SYMPTOMS. THIS NEW DEVICE HAS BEEN TOLERATED AT THE SAME SITE, WITHOUT ANY PROBLEMS, FOR 12 WEEKS. ADDITIONAL INFORMATION HAD BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508903 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention