rsRolesWithAccess DOES NOT exist
InDevEnvironment=false
rsRolesWithAccess numRows = [0]
IsInternalUser=[false]
InDevEnvironment=[false]
IsSectionSecure=[false]
Authorized=[false]
LMSAccess=[false]
HasNeuroHCP=[false]
UserLoggedIn=[false]
Loading

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.


    Follow-Up Letter – September 2014

    Urgent Medical Device Removal – July 2014

    Ascenda Intrathecal Catheters and Kits

    Models Affected:
    8780, 8781, 8784

    Medtronic conducted a voluntary removal of specific lots of the Ascenda Intrathecal Catheters and Ascenda Revision Kits. Ascenda catheters are used with the implantable Medtronic SynchroMed® drug infusion pump. The voluntary removal was conducted due to a single component of the catheter not meeting our specification criteria. A follow-up letter has been sent to physicians associated with patient(s) implanted with one of these catheters prior to the July 2014 notification. Medtronic’s testing related to this issue is completed, and these catheters have no increased risk for this component’s performance.

    Follow Up Letter (September 2014)  

    Customer Letter (July 2014)


    Product Advisories Archive

     

    2014

    DATEADVISORYAFFECTED PRODUCTS
    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