French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
ANSM has been informed of the implementation of a recall made by Medtronic. The users concerned received the attached mail (23/04/2015) (253 KB). This safety action is registered with the ANSM under the number 201504923 .. You will have the possibility of consulting its progress report on the Directory of the reports of materialovigilanc. by entering this registration number.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a withdrawal of products by the company MEDTRONIC INC .. The users concerned have received the attached mail (16/03/2016) (253 KB). This safety action is registered with the ANSM under the number 201603222. You will be able to consult its progress on the Directory of the signaling of materialovigilanc. by entering this registration number.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
In agreement with Afssaps and following the discovery of a manufacturing defect on certain devices, the company MEDTRONIC proceeded on June 5, 2008, at the recall of implantable pump lots Synchromed models 8637-20 and 8637-40 not still implanted mentioned in the attached mail and has issued recommendations for the management of patients already implanted by these lots. The implant doctors of these pumps, the directors and local correspondents of materiovigilance of the health establishments concerned in France received the mail of recommendations attached (05/06/2008) (269 ko). The directors and local correspondents of materiovigilance of the health establishments concerned in France have received the attached recall (05/06/2008) (33 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Notas adicionales en la data
Causa
The clinician refill reference card for synchromed® implantable infusion systems that was originally distributed with the january 2011 medical device correction related to pocket fills has been updated to align with new product labeling. the january 2011 medical device correction letter provided important reminders concerning the potential for a pocket fill during a synchromed ii or synchromed el implantable drug pump refill procedure, and important patient management recommendations. a pocket fill is the inadvertent injection of all or some of the prescribed drug into the patient's subcutaneous tissue, which includes the pump pocket, instead of the pump. .
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Notas adicionales en la data
Causa
The synchromed priming bolus function is intended to quickly advance drug from the pump reservoir to
the catheter tip to allow for therapy initiation while the patient remains under medical supervision.
although drug is not intended to be delivered to the cerebrospinal fluid (csf) during the priming bolus,
mixing of the drug and non-drug (sterile water/csf) fluids occurs at the high infusion rates used during
a priming bolus. mixing results in the unintended delivery of drug prior to the end of the programmed
bolus, as well as dilution of some of the drug remaining in the catheter at the end of the bolus. patients
will receive unintended drug at a high rate of infusion in the csf during the priming bolus, and a period
of reduced concentration of drug will occur following the priming bolus. .
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Notas adicionales en la data
Causa
Based on data collected from medtronic's implantable systems performance registry, the overall failure rate for a synchromed ii pump during the 78 months after installation is 2.4% if used to administer approved drugs, and 7.0% if used for administration of unapproved drugs. the use of unapproved drugs may cause temporary or permanent downtime of the pump motor, which have been reported as loss of therapy or change of therapy.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Notas adicionales en la data
Causa
Within the synchromed pump, feedthroughs are components that provide an electrically insulated path for current to flow from the electroniccircuitry to the motor. an electrical short can occur when ions from the drug solution and humidity permeate through the drug pathway tubing inside the pump and interact with the feedthrough over time. an electrical short circuit in a feedthrough may present as a motorstall or low battery reset/alarm and leadto a loss of or reduction in therapy which may result in the return of underlying symptoms and/or withdrawal symptoms. synchromed pump internal feedthrough shorts can lead to a loss of or reduction in therapy which may
result in a return of underlying symptoms and/or withdrawal symptoms.Patients receiving intrathecal
baclofen therapy are at risk for baclofen withdrawal syndrome, which can lead to a life threatening
condition if not promptly and effectively treated.Surgical revision to replace or remove the pumps may
be required for patients with pumps experiencing repeated motor stalls, low battery resets (with or
without safe state), or a premature elective replacement indicator.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Notas adicionales en la data
Causa
This letter provides important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the synchromed®implantable infusion pump. this unintended delivery of drug can contribute to patient overdose or underdose symptoms which may be clinically relevant.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Notas adicionales en la data
Causa
The clinician refill reference card for synchromed® implantable infusion systems that was originally distributed with the january 2011 medical device correction related to pocket fills has been updated to align with new product labeling. the january 2011 medical device correction letter provided important reminders concerning the potential for a pocket fill during a synchromed ii or synchromed el implantable drug pump refill procedure, and important patient management recommendations. a pocket fill is the inadvertent injection of all or some of the prescribed drug into the patient's subcutaneous tissue, which includes the pump pocket, instead of the pump.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Notas adicionales en la data
Causa
The overall failure rate for the synchromed ii pump during the 78 months after installation is 2.4% if used to administer approved drugs, and 7.0% if used to administer unapproved drugs. the use of unapproved drugs may cause temporary or permanent downtime of the pump motor, which have been reported as a loss of therapy or a change in therapy. changes to therapy can cause serious injury and / or death.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Removal from the market of certain batches of the product "Model 8551 filling kit used with Synchromed implantable infusion pumps", manufactured by Medtronic Inc, USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Update of the Model 8870 software card used in the N'VisionTM 8840 Medical Programmer and the instructions for use of the SynchroMed® II Implantable Infusion Systems, manufactured by Medtronic Inc, USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Possible appearance on the screen of the N'Vision medical programmer, manufactured by Medtronic Inc., of an incorrect replacement date for SynchroMed® II pumps that may result in the pump reaching the end of its life before replacement .
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Possibility of certain problems with the Synchromed II® and Synchromed EL implantable pumps, manufactured by Medtronic Inc., USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Information on SynchroMed II Implantable Infusion Pumps, manufactured by Medtronic Inc., USA
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Withdrawal from the market of certain "SynchroMed® II" infusion pumps, not implanted, models 8637-20 and 8637-40, manufactured by Medtronic Inc., USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Risk of overinfusion with the SynchroMed II implantable pump, manufactured by Medtronic, Inc., USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Update of the information regarding the risk of overinfusion with the SynchroMed II implantable pump, manufactured by Medtronic, Inc., USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Updating model 8870 of the software application card of the N'Vision medical programmer to correct problems affecting the Synchromed II pumps and devices for deep brain, spinal cord and peripheral nerve stimulation.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Possibility of increasing the risk of stops in the motor of the SynchroMed® implantable infusion pump due to the use of non-approved pharmacological formulations for this pump
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Withdrawal from the market of certain implantable drug infusion pumps "SynchroMed® II", and recommendations for the follow-up of patients implanted with them, due to a possible interruption in the operation of the audible alarm.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Safety warning related to the lower reliability of Synchromed II pumps when used with non-approved drugs and communication of a design change to reduce the possibility of an engine shutdown.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Removal of unused Synchromed® II implantable drug infusion pumps from the market, with an expiration date equal to or prior to December 31, 2018, and replacement by pumps with an improved motor design.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the Netherlands.
Notas adicionales en la data
Causa
Update regarding the communication of 2011, for pumps that have been manufactured up to and including june 2011.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the Netherlands.
Notas adicionales en la data
Causa
The purpose of this letter is to inform you that medtronic has received approval for the implementation of an adaptation in the design of the synchromed® ii implantable infusion pump, reducing the risk of irreparable engine blocking (motor stall) interrupted, reduces.