BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 2962189 · Received February 14, 2013

    Report

    Report Number
    3007566237-2013-00491
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    February 5, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER: MODEL: UNK, SERIAL/LOT#: UNK, IMPLANTED: UNK, EXPLANTED: UNK. IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH ANY PREVIOUSLY REPORTED EVENTS. (B)(4).

    Description of Event or Problem · 1

    ALETON E, DECAVEL P, MICHEL F, BEVALOT J, GODARD J, PARRATTE B. INTRATHECAL BACLOFEN FOR SPASTICITY MANAGEMENT: A COMPARATIVE ANALYSIS OF COMPLICATIONS IN A SERIES OF 88 PUMPS FOR ADULTS AND CHILDREN. ANNALS OF PHYSICAL AND REHABILITATION MEDICINE. 2012;55(SUPPL 1):E336+E339. SUMMARY: THE OBJECTIVE WAS TO EXAMINE DIFFERENCES IN COMPLICATION RATES BETWEEN CHILDREN AND ADULTS TREATED BY INTRATHECAL BACLOFEN. MATERIAL AND METHOD.- RETROSPECTIVE CHART REVIEW OF 73 PATIENTS (ADULTS AND CHILDREN; 88 PUMPS) WITH A DIAGNOSIS OF SEVERE SPASTICITY REQUIRING INTRATHECAL BACLOFEN THERAPY. COMPLICATION RATES BY CATEGORY WERE AS FOLLOWS: RELATED TO HUMAN ERROR: 8%, RELATED TO BACLOFEN: 11%, RELATED TO SURGERY: 19% AND RELATED TO THE IMPLANTABLE DEVICE: 27%. COMPLICATIONS WERE MORE FREQUENT IN ADULTS THAN IN CHILDREN, EXCEPT FOR COMPLICATIONS RELATED TO SURGERY. THE COMPLICATION RATE RELATED TO THE IMPLANTABLE DEVICE WAS HIGHER IN AMBULATORY PATIENTS. THE COMPLICATION RATES RELATED TO SURGERY AND THE IMPLANTABLE DEVICE DECREASED DURING THE COURSE OF THE STUDY. CONCLUSIONS - THE OVERALL COMPLICATION RATE OBSERVED IN OUR SERIES IS COMPARABLE TO THAT REPORTED IN THE LITERATURE AND, IN CONTRAST WITH THE LITERATURE, WAS NOT HIGHER IN CHILDREN THAN IN ADULTS. ONLY COMPLICATIONS RELATED TO THE SURGICAL PROCEDURE WERE SLIGHTLY MORE COMMON IN CHILDREN. BACLOFEN PUMP IMPLANTATION IN CHILDREN IS THEREFORE A SAFE PROCEDURE. REPORTED EVENTS: RETROSPECTIVE CHART REVIEW OF 73 PATIENTS (ADULTS AND CHILDREN; 88 PUMPS) WITH A DIAGNOSIS OF SEVERE SPASTICITY REQUIRING INTRATHECAL BACLOFEN THERAPY. COMPLICATION RATES BY CATEGORY WERE AS FOLLOWS: RELATED TO HUMAN ERROR: 8%, RELATED TO BACLOFEN: 11%, RELATED TO SURGERY:19% AND RELATED TO THE IMPLANTABLE DEVICE: 27%. COMPLICATIONS WERE MORE FREQUENT IN ADULTS THAN IN CHILDREN, EXCEPT FOR COMPLICATIONS RELATED TO SURGERY. THE COMPLICATION RATE RELATED TO THE IMPLANTABLE DEVICE WAS HIGHER IN AMBULATORY PATIENTS. THE COMPLICATION RATES RELATED TO SURGERY AND THE IMPLANTABLE DEVICE DECREASED DURING THE COURSE OF THE STUDY. THE NATURE OF THE COMPLICATIONS WAS NOT SPECIFIED. ADDITIONAL INFORMATION IS BEING REQUESTED AT THIS TIME; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64356 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention