BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDSTREAM REFILL KIT

    MDR report key: 7001234 · Received November 3, 2017

    Report

    Report Number
    8031062-2017-00008
    Event Type
    Injury
    Date Received
    November 3, 2017
    Report Date
    September 5, 2017
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR, MFR REPORT #8031062-2017-00008, IS BEING SUBMITTED AS A FOLLOW-UP/FINAL REPORT TO INITIAL MDR, MFR REPORT #1226348 - 2017 - 10712. MFR REPORT #1226348 - 2017 - 10712 WAS SUBMITTED BY CODMAN NEUROSURGICAL. AS CODMAN NEUROSURGICAL WAS DIVESTED TO INTEGRA LIFE SCIENCES ON (B)(4) 2017, CODMAN NEUROVASCULAR HAS TAKEN ON RESPONSIBILITY FOR THIS DEVICE AND WILL. ADDITIONALLY, THIS FOLLOW-UP MDR IS BEING SUBMITTED TO CORRECT THE CATALOG NUMBER. IT HAD PREVIOUSLY BEEN REPORTED AS A MEDSTREAM PUMP 20ML; HOWEVER, THE COMPLAINT IS ACTUALLY AGAINST AN UNKNOWN MEDSTREAM REFILL KIT (PRODUCT CODE /LOT NUMBER ARE UNKNOWN). CONCLUSION: BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED BECAUSE THE LOT FOR THE PRODUCT IS UNKNOWN. SINCE THE EVENT COULD NOT BE CONFIRMED AND THERE IS NO EVIDENCE OF A MANUFACTURING-RELATED MALFUNCTION, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THIS FINAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2017-00008. CONCLUSION: BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED BECAUSE THE LOT FOR THE PRODUCT IS UNKNOWN. THERE WERE NO SIGNIFICANT SAFETY SIGNALS IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON A REVIEW OF COMPLAINT HISTORY FOR THE DEVICE. SINCE THE EVENT COULD NOT BE CONFIRMED AND THERE IS NO EVIDENCE OF A MANUFACTURING-RELATED MALFUNCTION, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿INTRATHECAL PUMP REFILLS, POCKET FILLS, AND SYMPTOMS OF DRUG OVERDOSE: A PROSPECTIVE, OBSERVATIONAL STUDY COMPARING THE INJECTED DRUG VOLUME VS. THE DRUG VOLUME EFFECTIVELY MEASURED INSIDE THE PUMP¿ BY PAOLO MAINO, MD; ROBERTO S.G.M. PEREZ, PHD; EVA KOETSIER, MD PUBLISHED NEUROMODULATION: TECHNOLOGY AT THE NEURAL INTERFACE DOI: 10.1111/NER.12597, IT WAS REPORTED THAT PATIENT # 11 HAD OVERDOSE SYMPTOMS AFTER MEDSTREAM PUMP REFILL WITH FENTANYL IN AUGUST 2015. PER THE ARTICLE: ¿ONE COMPLICATION ASSOCIATED WITH THE REFILL PROCEDURE OF INTRATHECAL DRUG DELIVERY SYSTEMS (IDDSS) INCLUDE A ¿POCKET FILL,¿ WHICH IS THE INADVERTENT INJECTION OF THE DRUG INTO THE SUBCUTANEOUS SPACE SURROUNDING THE PUMP. THE PURPOSE OF OUR STUDY WAS TO ASSESS THE MEAN VOLUME DISCREPANCY BETWEEN THE INJECTED AND THE EFFECTIVE DRUG VOLUME INSIDE THE IDDS RESERVOIR AFTER REFILLS THAT DID NOT LEAD TO SIGNS OF OVERDOSE AND TO RECORD AT WHICH VOLUME DISCREPANCY SYMPTOMS OF OVERDOSE WERE NOTICED¿. THE MEDIAN VOLUME DISCREPANCY IN THE 20 ML IDDSS WAS 0.40 ML (IQR: 0.18¿0.61; 10THP: 0.0; 90THP: 0.74) WHEREAS IN THE 40 ML IDDSS THE MEDIAN VOLUME DISCREPANCY WAS 1.3 ML (IQR: 1.06¿1.74; 10THP: 0.81; 90THP: 2.2). SYMPTOMS OF OVERDOSE WERE OBSERVED AFTER 6 OUT OF THE 221 REFILL PROCEDURES. VOLUMES AT WHICH THE SYMPTOMS OF OVERDOSE AROSE WERE BETWEEN 1.15 AND 4.5 ML IN 20 ML IDDSS AND BETWEEN 2.08 AND 4.88 ML IN 40 ML IDDSS¿..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777983 MEDSTREAM REFILL KIT INFUSION PUMP, IMPLANTABLE, PROGRAMMABLE LKK MEDOS INTERNATIONAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention