Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Potential for a pocket fill during a synchromed ii or synchromed el implantable drug pump refill procedure.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Important safety information on synchromed ii and synchromed el infusion pumps to healthcare professionals regarding the following: 1.Pump refill procedure safety update: update to the of january 18 2011 medical device safety alert letter titled "important clinical information about pocket fills" 2.Synchromedr implantable infusion pump internal shorting: provide safety information and patient management recommendations related the potential for electrical shorting internal to the synchromed infusion pump. 3.Synchromedr implantable infusion pump priming bolus: important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the synchromedr implantable infusion pump.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Provide important new information regarding overinfusion associated with the synchromed ii implantable pump.Overinfusion is defined as an infusion rate exceeding the programmed infusion rate by more than 14.5% as described in the labeling. when overinfusion occurs it will result in a volume discrepancy at pump refill where the volume withdrawn from the pump is less than the volume expected. overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk medtronic is not recommending prophylactic replacement of pumps.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Medtronic is updating the model 8870 software application card (to version bbuo1) as well as the synchromed infusion system labeling to address the unintended delivery of drug during the priming bolus function. 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. the updated 8870 software card mitigates the potential for clinically relevant effects of over-delivery of unintended drug such as respiratory depression loss of consciousness or death during the full system priming bolus procedure. the therapy applications on the software card for deep brain stimulation and spinal cord stimulation remain unchanged. this recall affects all 8870 software application cards which are used in the 8840 n'vision clinical programmers. the 8870 software application card is listed under multiple licence numbers which pertain to specific sets of devices that work together.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
The model 8840 physician programmer may display an incorrect "schedule to replace the pump by" date for the model 8637 synchromed ii implantable drug infusion pump. in some circumstances after a pump's eri has occurred the date may be displayed as a series of question marks or as a date greater than 90 days from the eri date potentially leading to the pump reaching end of service prior to replacement. this issue may only occur if the 90days after eri notification falls on the first day of a month. it does not affect pump function or alarms. this is due to a software error specific to the model 8870 application card software for the synchromed ii pump.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
This field action is to provide an update to important safety information and patient management recommendations related to the potential for reduced battery performance in a small percentage of synchromedr ii pumps.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
A small number of synchromed ii implantable infusion pumps may have been manufactured without propellant.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
The medical device correction includes the distribution of a new 8870 software application card version bbr/01 (revision b) which provides updates to the 8840 clinician programmer used to program medtronic spinal cord stimulators deep brain stimulators and the synchromedr ii implantable infusion system. for scs and dbs therapy: the new software provides an automatic transfer of new internal device software from the 8840 to implantable and implanted devices. this change addresses loss of stimulation caused by the exception bit behavior. this behavior is also known as error code 509. in addition the notification provides information about the potential for over stimulation or stimulation in the wrong area under a specific set of conditions typically related to device recovery from an over discharge. for synchromed ii pump therapy: the update includes correction of the issue previously communicated in the march 2012 medical device correction regarding the potential for the model 8840 n'vision clinician programmer to display an erroneous replace by date (erbd) "schedule to replace pump by" (date when used with the synchromed ii pump. the updated software also corrects the potential for premature low and empty reservoir alarms with the synchromed ii pump. these premature alarms are due to an incorrect calculation within the 8840 programmer software. no changes are being made to the implantable synchromedr ii pump device as a result of this update.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
The investigation report (ir) for synchromed ii pump corrosion defines the problem statement as the "degradation of synchromed ii motor components due to corrosion wear and a combination of corrosion and wear can result in temporary intermittent and/or permanent motor stall." the root cause of failure is identified as the depletion of lubricant at the shaft/jewel bearing interface which initiates mechanical wear on shaft ends resulting in wear particles that can mix with the remaining lubricant creating residue. shaft wear results in temporary or permanent motor stall.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
This field action is a follow-up to medtronic customer notification regarding synchromedr ii model 8637. medtronic is now exchanging non-implanted synchromedr ii pumps containing the original design batteries with pumps containing the new batteries.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic issued a letter to healthcare professionals providing important safety information regarding mri (magnetic resonance imaging) effects on synchromed el and synchromed ii implantable infusion pumps. as stated in product labeling, the magnetic field of an mri will temporarily stop the rotor of the pump motor and suspend drug infusion for the duration of mri exposure for all synchromed pump.
Acción
An Urgent Medical Device Correction, Important Information on Potential MRI Effects letter, dated August 2008, was sent to health care professionals beginning August 25, 2008. The letter described the issue, provided patient management recommendations and included enclosures: Roller Study Procedure to confirm pump function, Post MRI Pump Interrogation Guidelines and New Information Regarding Potential MRI Effects.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic issued a letter to healthcare professionals providing important safety information regarding mri (magnetic resonance imaging) effects on synchromed el and synchromed ii implantable infusion pumps. as stated in product labeling, the magnetic field of an mri will temporarily stop the rotor of the pump motor and suspend drug infusion for the duration of mri exposure for all synchromed pump.
Acción
An Urgent Medical Device Correction, Important Information on Potential MRI Effects letter, dated August 2008, was sent to health care professionals beginning August 25, 2008. The letter described the issue, provided patient management recommendations and included enclosures: Roller Study Procedure to confirm pump function, Post MRI Pump Interrogation Guidelines and New Information Regarding Potential MRI Effects.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic issued a letter to healthcare professionals providing important safety information regarding mri (magnetic resonance imaging) effects on synchromed el and synchromed ii implantable infusion pumps. as stated in product labeling, the magnetic field of an mri will temporarily stop the rotor of the pump motor and suspend drug infusion for the duration of mri exposure for all synchromed pump.
Acción
An Urgent Medical Device Correction, Important Information on Potential MRI Effects letter, dated August 2008, was sent to health care professionals beginning August 25, 2008. The letter described the issue, provided patient management recommendations and included enclosures: Roller Study Procedure to confirm pump function, Post MRI Pump Interrogation Guidelines and New Information Regarding Potential MRI Effects.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic issued a letter to healthcare professionals providing important safety information regarding mri (magnetic resonance imaging) effects on synchromed el and synchromed ii implantable infusion pumps. as stated in product labeling, the magnetic field of an mri will temporarily stop the rotor of the pump motor and suspend drug infusion for the duration of mri exposure for all synchromed pump.
Acción
An Urgent Medical Device Correction, Important Information on Potential MRI Effects letter, dated August 2008, was sent to health care professionals beginning August 25, 2008. The letter described the issue, provided patient management recommendations and included enclosures: Roller Study Procedure to confirm pump function, Post MRI Pump Interrogation Guidelines and New Information Regarding Potential MRI Effects.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic issued a letter to healthcare professionals providing important safety information regarding mri (magnetic resonance imaging) effects on synchromed el and synchromed ii implantable infusion pumps. as stated in product labeling, the magnetic field of an mri will temporarily stop the rotor of the pump motor and suspend drug infusion for the duration of mri exposure for all synchromed pump.
Acción
An Urgent Medical Device Correction, Important Information on Potential MRI Effects letter, dated August 2008, was sent to health care professionals beginning August 25, 2008. The letter described the issue, provided patient management recommendations and included enclosures: Roller Study Procedure to confirm pump function, Post MRI Pump Interrogation Guidelines and New Information Regarding Potential MRI Effects.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic issued a letter to healthcare professionals providing important safety information regarding mri (magnetic resonance imaging) effects on synchromed el and synchromed ii implantable infusion pumps. as stated in product labeling, the magnetic field of an mri will temporarily stop the rotor of the pump motor and suspend drug infusion for the duration of mri exposure for all synchromed pump.
Acción
An Urgent Medical Device Correction, Important Information on Potential MRI Effects letter, dated August 2008, was sent to health care professionals beginning August 25, 2008. The letter described the issue, provided patient management recommendations and included enclosures: Roller Study Procedure to confirm pump function, Post MRI Pump Interrogation Guidelines and New Information Regarding Potential MRI Effects.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic issued a letter to healthcare professionals providing important safety information regarding mri (magnetic resonance imaging) effects on synchromed el and synchromed ii implantable infusion pumps. as stated in product labeling, the magnetic field of an mri will temporarily stop the rotor of the pump motor and suspend drug infusion for the duration of mri exposure for all synchromed pump.
Acción
An Urgent Medical Device Correction, Important Information on Potential MRI Effects letter, dated August 2008, was sent to health care professionals beginning August 25, 2008. The letter described the issue, provided patient management recommendations and included enclosures: Roller Study Procedure to confirm pump function, Post MRI Pump Interrogation Guidelines and New Information Regarding Potential MRI Effects.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic issued a letter to healthcare professionals providing important safety information regarding mri (magnetic resonance imaging) effects on synchromed el and synchromed ii implantable infusion pumps. as stated in product labeling, the magnetic field of an mri will temporarily stop the rotor of the pump motor and suspend drug infusion for the duration of mri exposure for all synchromed pump.
Acción
An Urgent Medical Device Correction, Important Information on Potential MRI Effects letter, dated August 2008, was sent to health care professionals beginning August 25, 2008. The letter described the issue, provided patient management recommendations and included enclosures: Roller Study Procedure to confirm pump function, Post MRI Pump Interrogation Guidelines and New Information Regarding Potential MRI Effects.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic issued a letter to healthcare professionals providing important safety information regarding mri (magnetic resonance imaging) effects on synchromed el and synchromed ii implantable infusion pumps. as stated in product labeling, the magnetic field of an mri will temporarily stop the rotor of the pump motor and suspend drug infusion for the duration of mri exposure for all synchromed pump.
Acción
An Urgent Medical Device Correction, Important Information on Potential MRI Effects letter, dated August 2008, was sent to health care professionals beginning August 25, 2008. The letter described the issue, provided patient management recommendations and included enclosures: Roller Study Procedure to confirm pump function, Post MRI Pump Interrogation Guidelines and New Information Regarding Potential MRI Effects.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic issued a letter to healthcare professionals providing important safety information regarding mri (magnetic resonance imaging) effects on synchromed el and synchromed ii implantable infusion pumps. as stated in product labeling, the magnetic field of an mri will temporarily stop the rotor of the pump motor and suspend drug infusion for the duration of mri exposure for all synchromed pump.
Acción
An Urgent Medical Device Correction, Important Information on Potential MRI Effects letter, dated August 2008, was sent to health care professionals beginning August 25, 2008. The letter described the issue, provided patient management recommendations and included enclosures: Roller Study Procedure to confirm pump function, Post MRI Pump Interrogation Guidelines and New Information Regarding Potential MRI Effects.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
This recall is related to the potential for reduced battery performance in a small percentage of medtronic model 8637 synchromed¿ ii pumps with batteries manufactured during two distinct time periods prior to april 2005.
nature of the device issue: as part of ongoing analysis of returned explanted product, medtronic has confirmed that reduced battery performance resulted in eight (8) occurrence.
Acción
Consignees were sent on July 7, 2009 a Medtronic " Urgent: Medical Device Correction" letter dated July 2009. The letter was addressed to Healthcare Professionals. The letter described the nature of the Device Issue, Scope, Potential Severity of the Issue, Recommendations, Ongoing patient Management Recommendations and Additional Information. Important patient management information is also available at http://www.professional.medtronic.com under the heading Product Advisories.
Direct questions to your Medtronic Field Representative or Medtronic Neuromodulation Technical Services by calling at 1-800-707-0933.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Intrathecal Catheter - Product Code LKK
Causa
Current labeling for medtronic sutureless connector (sc) catheters and revision kits (hereafter referred to as sc catheters ) incorrectly states that sc catheters are compatible with medtronic isomed¿ constant-flow infusion pumps. sc catheters are compatible with medtronic synchromed¿ ii and synchromed el pumps. medtronic has determined that sc catheters are not compatible with isomed pumps.
Acción
A "Medical Device Correction Notification" letter was issued on August 14, 2009 to implanting and managing physicians. The letter described the nature of the issue, scope of affected product, potential severity of the issue and provided recommendations. Physicians were instructed that Sutureless Connector (SC) catheters must not be used with IsoMed pumps for future revisions and implants.
A copy of the letter was also sent to the Risk Manager at each hospital associated with physicians using SC catheters. Healthcare professionals were asked to complete and return the enclosed reply card.
Direct questions to your Medtronic field representative or contact Medtronic Neuromodulation Technical Services at 1-800-707-0933. Patient Management information is also available at http://www.professional.medtronic.com under the Heading, "Advisories".
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Intrathecal Catheter - Product Code LKK
Causa
Current labeling for medtronic sutureless connector (sc) catheters and revision kits (hereafter referred to as sc catheters ) incorrectly states that sc catheters are compatible with medtronic isomed¿ constant-flow infusion pumps. sc catheters are compatible with medtronic synchromed¿ ii and synchromed el pumps. medtronic has determined that sc catheters are not compatible with isomed pumps.
Acción
A "Medical Device Correction Notification" letter was issued on August 14, 2009 to implanting and managing physicians. The letter described the nature of the issue, scope of affected product, potential severity of the issue and provided recommendations. Physicians were instructed that Sutureless Connector (SC) catheters must not be used with IsoMed pumps for future revisions and implants.
A copy of the letter was also sent to the Risk Manager at each hospital associated with physicians using SC catheters. Healthcare professionals were asked to complete and return the enclosed reply card.
Direct questions to your Medtronic field representative or contact Medtronic Neuromodulation Technical Services at 1-800-707-0933. Patient Management information is also available at http://www.professional.medtronic.com under the Heading, "Advisories".
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Current labeling for medtronic sutureless connector (sc) catheters and revision kits (hereafter referred to as sc catheters ) incorrectly states that sc catheters are compatible with medtronic isomed¿ constant-flow infusion pumps. sc catheters are compatible with medtronic synchromed¿ ii and synchromed el pumps. medtronic has determined that sc catheters are not compatible with isomed pumps.
Acción
A "Medical Device Correction Notification" letter was issued on August 14, 2009 to implanting and managing physicians. The letter described the nature of the issue, scope of affected product, potential severity of the issue and provided recommendations. Physicians were instructed that Sutureless Connector (SC) catheters must not be used with IsoMed pumps for future revisions and implants.
A copy of the letter was also sent to the Risk Manager at each hospital associated with physicians using SC catheters. Healthcare professionals were asked to complete and return the enclosed reply card.
Direct questions to your Medtronic field representative or contact Medtronic Neuromodulation Technical Services at 1-800-707-0933. Patient Management information is also available at http://www.professional.medtronic.com under the Heading, "Advisories".
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Current labeling for medtronic sutureless connector (sc) catheters and revision kits (hereafter referred to as sc catheters ) incorrectly states that sc catheters are compatible with medtronic isomed¿ constant-flow infusion pumps. sc catheters are compatible with medtronic synchromed¿ ii and synchromed el pumps. medtronic has determined that sc catheters are not compatible with isomed pumps.
Acción
A "Medical Device Correction Notification" letter was issued on August 14, 2009 to implanting and managing physicians. The letter described the nature of the issue, scope of affected product, potential severity of the issue and provided recommendations. Physicians were instructed that Sutureless Connector (SC) catheters must not be used with IsoMed pumps for future revisions and implants.
A copy of the letter was also sent to the Risk Manager at each hospital associated with physicians using SC catheters. Healthcare professionals were asked to complete and return the enclosed reply card.
Direct questions to your Medtronic field representative or contact Medtronic Neuromodulation Technical Services at 1-800-707-0933. Patient Management information is also available at http://www.professional.medtronic.com under the Heading, "Advisories".