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Targeted Drug Delivery

  • Education and Training
  • Efficacy
  • Products and Procedures
  • Reimbursement and Practice Management
  • Indications, Safety, and Warnings
  • Product Advisories

    Medtronic is committed to providing you with the highest quality products and services and ongoing support.

    As part of our commitment, we have created this forum to house important information learned from ongoing use and experience with our products. We believe the content of these product advisories will further patient safety and improve outcomes.


    Urgent Medical Device Correction – April 2015

    SynchroMed II Implantable Drug Infusion Pump Audible Alarm

    Models Affected:
    8637-20, 8637-40

    This physician communication provides important information regarding a potential malfunction of the audible alarm of a finite subset of Model 8637-20 and 8637-40 SynchroMed® II implantable drug pumps (based on serial number). The cause of this issue has been addressed, and therefore only products identified by this notification are potentially affected. Medtronic is not recommending prophylactic replacement of pumps due to the low projected rate of occurrence of this issue.

    This communication is based on information available to date and was developed in collaboration with clinical experts. Read on for detailed information related to this communication.

    Healthcare Professional Letter

    This letter provides information regarding the issue, along with patient management recommendations.

    Instructions to Initiate an Alarm Test on the 8840 Clinician Programmer

    These instructions explain the steps required to initiate an alarm test using the 8840 Clinician Programmer during a patient visit.

    Instructions to Review Event Logs on the 8840 Clinician Programmer

    These instructions explain the steps required to review event logs using the 8840 Clinician Programmer after interrogating the pump.

    synchromed2alarm.medtronic.com

    This web-based tool can be used to identify whether a specific SynchroMed II pump is potentially affected by this audible alarm issue based on pump serial number.


    Product Advisories Archive

     

    2014

    DATEADVISORYAFFECTED PRODUCTS

    09/2014

    Ascenda Intrathecal Catheters and Kits - Follow-Up Letter

    8780, 8781, 8784

    07/2014

    Ascenda Intrathecal Catheters and Kits

    8780, 8781, 8784

    03/2014 SynchroMed II Implantable Drug Infusion Pump Overinfusion SynchroMed II Implantable Drug Infusion Pump

    2013

    DATEADVISORYAFFECTED PRODUCTS
    09/2013 Model 8870 Software Application Card used in the 8840 N’Vision Clinician Programmer N'Vision Clinician Programmer
    Model 8840
    06/2013 SynchroMed Implantable Infusion Pump Priming Bolus SynchroMed® II and SynchroMed EL
    06/2013 SynchroMed Implantable Infusion Pump Internal Shorting SynchroMed® II and SynchroMed EL
    06/2013 Update to the January 2011 Medical Device Correction letter titled “Important Clinical Information about Pocket Fills” SynchroMed® II and SynchroMed EL
    05/2013 Medical Device Removal – May 2013 Sutureless Connector Intrathecal Catheter Products Models: 8709SC, 8731SC, 8596SC, 8578 (with Use by Date prior to 25 Aug 2014)

    2012

    2011

    2010

    DATEADVISORYAFFECTED PRODUCTS
    09/2010 Medical Device Recall – Potential Endotoxin Issue

    Model 8731SC Intrathecal Catheter Kit and
    Model 8598A Spinal Segment Revision Kit

    08/2010 Medical Device Correction – Cephalad Migration of Catheter Fragments

    Model 8626 SynchroMed EL
    Model 8627 SynchroMed EL
    Model 8637-20 SynchroMed II
    Model 8637-40 SynchroMed II
    Model 8472-20 IsoMed
    Model 8472-35 IsoMed
    Model 8472-60 IsoMed

    2009

    DATEADVISORYAFFECTED PRODUCTS
    08/2009 Medical Device Correction – Sutureless Connector (SC) Intrathecal Catheters

    Model 8472-20 IsoMed
    Model 8472-35 IsoMed
    Model 8472-60 IsoMed
    Model 8079SC Intrathecal Catheter
    Model 8731SC Intrathecal Catheter
    Model 8596SC Intrathecal Catheter Proximal Revision Kit
    Model 8578 Sutureless Pump Connector Revision Kit

    07/2009 Medical Device Correction – Battery Performance

    Model 8637-20 SynchroMed II
    Model 8637-40 SynchroMed II

    02/2009 Medical Device Correction – Software Application Card for SynchroMed II Infusion Systems

    Model 8840 N’Vision® Clinician Programmer

    2008

    DATEADVISORYAFFECTED PRODUCTS
    08/2008 Medical Device Correction – Important Information on Potential MRI Effects

    Model 8626 SynchroMed EL
    Model 8627 SynchroMed EL
    Model 8637-20 SynchroMed II
    Model 8637-40 SynchroMed II

    06/2008 Medical Device Safety Alert – Proper Connection of Sutureless Connector Intrathecal Catheters

    Model 8079SC Intrathecal Catheter
    Model 8731SC Intrathecal Catheter
    Model 8596SC Intrathecal Catheter Proximal Revision Kit
    Model 8578 Sutureless Pump Connector Revision Kit

    05/2008 Medical Device Recall – Missing Propellant

    Model 8637-20 SynchroMed II
    Model 8637-40 SynchroMed II

    01/2008 Medical Device Correction – Inflammatory Mass (Granuloma) at or Near the Distal Tip of Intrathecal Catheters

    Model 8616 SynchroMed
    Model 8617 SynchroMed
    Model 8626 SynchroMed EL
    Model 8627 SynchroMed EL
    Model 8637-20 SynchroMed II
    Model 8637-40 SynchroMed II
    Model 8472-20 IsoMed
    Model 8472-35 IsoMed
    Model 8472-60 IsoMed

    2007

    DATEADVISORYAFFECTED PRODUCTS
    08/2007 Medical Device Correction – Pump Motor Stall Due to Shaft Wear

    Model 8626 SynchroMed EL
    Model 8627 SynchroMed EL

    2006

    DATEADVISORYAFFECTED PRODUCTS
    11/2006 Educational Brief – Patient Mortality after Implant and Initiation of Intrathecal Infusion Therapy for Pain

    Model 8626 SynchroMed EL
    Model 8627 SynchroMed EL

    07/2006 Medical Device Recall

    Model 8731SC Intrathecal Catheter
    Model 8578 Sutureless Pump Connector Revision Kit

    05/2006 Medical Device Recall

    Model 8627 SynchroMed EL

    01/2006 Educational Brief – Drug Delivery Pumps and Drug Formulations Containing Preservatives

    Model 8616 SynchroMed
    Model 8617 SynchroMed
    Model 8626 SynchroMed EL
    Model 8627 SynchroMed EL
    Model 8637-20 SynchroMed II
    Model 8637-40 SynchroMed II
    Model 8472-20 IsoMed
    Model 8472-35 IsoMed
    Model 8472-60 IsoMed

    United States