BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 5673052 · Received May 23, 2016

    Report

    Report Number
    3007566237-2016-02076
    Event Type
    Injury
    Date Received
    May 23, 2016
    Date of Event
    February 26, 2016
    Report Date
    May 23, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED AGE REFLECTS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE LITERATURE ARTICLE. THE REPORTED SEX REFLECTS THAT OF THE MAJORITY OF THE PATIENTS REPORTED IN THE LITERATURE ARTICLE. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_PUMP, LOT# UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE: CATHETER.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SPADER, H.S., BOLLO, R.J., BOWERS, C.A., RIVA-CAMBRIN, J. RISK FACTORS FOR BACLOFEN PUMP INFECTION IN CHILDREN: A MULTIVARIATE ANALYSIS. JOURNAL OF NEUROSURGERY. PEDIATRICS. 2016:1-7. DOI: 10.3171/2015.11.PEDS15421. SUMMARY: INTRATHECAL BACLOFEN INFUSION SYSTEMS TO MANAGE SEVERE SPASTICITY AND DYSTONIA ARE ASSOCIATED WITH HIGHER INFECTION RATES IN CHILDREN THAN IN ADULTS. FACTORS UNIQUE TO THIS POPULATION, SUCH AS POOR NUTRITION AND PHYSICAL LIMITATIONS FOR PUMP PLACEMENT, HAVE BEEN HYPOTHESIZED AS THE REASONS FOR THIS DISPARITY. THE AUTHORS ASSESSED POTENTIAL RISK FACTORS FOR INFECTION IN A MULTIVARIATE ANALYSIS. REPORTED EVENTS: SIX PATIENTS HAD EITHER SUPERFICIAL OR DEEP WOUND DEHISCENCE. ONE PATIENT HAD WOUND DEHISCENCE AND EROSION WITH VISIBLE HARDWARE. THIS PATIENT WAS CONSIDERED TO BE INFECTED BUT DID NOT HAVE A POSITIVE CULTURE. TEN PATIENTS HAD CEREBROSPINAL FLUID (CSF) LEAK. FIVE OF THE INFECTIONS WERE METHICILLIN-RESISTANT STAPH AUREUS. ELEVEN OF THE INFECTIONS WERE METHICILLIN-SENSITIVE STAPH AUREUS. TWO OF THE INFECTIONS WERE STAPH EPIDERMIS. ONE INFECTION WAS STAPH CAPITAS. TWO INFECTIONS WERE DUE TO PSEUDOMONAS SPECIES. ONE INFECTION WAS DUE TO PROPIONIBACTERIUM ACNES. ONE INFECTION WAS DUE TO ENTEROCOCCUS FAECALIS. ONE INFECTION WAS DUE TO GRAM-NEGATIVE BACILLI. REVISIONS WITHIN 6 MONTHS OF PUMP PLACEMENT WERE ALL ASSOCIATED WITH HIGHER INFECTION RATES. THE CAUSE OF THE REVISIONS WERE NOT NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328549 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention