BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN 3000

    MDR report key: 7001005 · Received November 3, 2017

    Report

    Report Number
    8031062-2017-00009
    Event Type
    Injury
    Date Received
    November 3, 2017
    Date of Event
    April 30, 2017
    Report Date
    August 17, 2017
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FINAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2017-00009. CONCLUSION: BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; HOWEVER A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEW OF COMPLAINT HISTORY FOR THE DEVICE. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THIS INITIAL MDR FOR MFR REPORT #8031062-2017-00009 IS BEING SUBMITTED AS A FOLLOW UP REPORT TO MFR REPORT #1226348-2017-10660. MFR REPORT #1226348-2017-10660 WAS INITIALLY REPORTED BY CODMAN NEUROSURGICAL ON SEPTEMBER 05, 2017, PRIOR TO THEIR DIVESTITURE TO INTEGRA LIFE SCIENCES. UDI: LOT NUMBER AND PRODUCT CODE UNKNOWN; UDI UNAVAILABLE. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY A PATIENT, AFTER 12 YEARS, A CODMAN 3000 PUMP IS NOT WORKING PROPERLY AND THE PATIENT IS EXPERIENCING WITHDRAWAL SYMPTOMS. PATIENT WANTS INFORMATION CONCERNING REPLACEMENT. THE DOCTOR WROTE IN THE NOTES THE PUMP IS NONFUNCTIONAL. THERE IS NO PLAN TO REMOVE THE PUMP AT THIS TIME. THE PATIENT DID PRESENT WITH SOME WITHDRAWAL SYMPTOMS AND WAS GIVEN ORAL AND TRANSDERMAL MEDICATION WHICH IS BEING CONTINUED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778583 CODMAN 3000 INFUSION PUMP, IMPLANTABLE, PROGRAMMABLE LKK MEDOS INTERNATIONAL SARL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention