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
Introducer, Catheter - Product Code DYB
Causa
Potential for a partial or complete separation of the shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. if either of these were to occur during use, it is likely that fluids would leak around the introducer hub and strain relief.
Acción
Consignees were sent "Urgent Medical Device Recall Notice" dated June 24, 2010 from St. Jude Medical . The letter was addressed to Cath Lab Manger/ Risk Manager. The letter described the problem and the product involved. Advised consignees to discontinue use of the product and remove from inventory.
Sales Representatives were also sent a St. Jude Medical Memorandum "Field Action Notice" dated June 24, 2010 and a reconciliation form. The memorandum described the problem and product. Advised Sales Rep to visit the affected accounts and to performed the assigned tasks.
A St. Jude Medical sales representative will be contacting for removal and replacement of the affected product. For additional information, please contact St. Jude Medical at 651-491-4470.
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
Introducer, Catheter - Product Code DYB
Causa
Potential for a partial or complete separation of the shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. if either of these were to occur during use, it is likely that fluids would leak around the introducer hub and strain relief.
Acción
Consignees were sent "Urgent Medical Device Recall Notice" dated June 24, 2010 from St. Jude Medical . The letter was addressed to Cath Lab Manger/ Risk Manager. The letter described the problem and the product involved. Advised consignees to discontinue use of the product and remove from inventory.
Sales Representatives were also sent a St. Jude Medical Memorandum "Field Action Notice" dated June 24, 2010 and a reconciliation form. The memorandum described the problem and product. Advised Sales Rep to visit the affected accounts and to performed the assigned tasks.
A St. Jude Medical sales representative will be contacting for removal and replacement of the affected product. For additional information, please contact St. Jude Medical at 651-491-4470.
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
Introducer, Catheter - Product Code DYB
Causa
Potential for a partial or complete separation of the shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. if either of these were to occur during use, it is likely that fluids would leak around the introducer hub and strain relief.
Acción
Consignees were sent "Urgent Medical Device Recall Notice" dated June 24, 2010 from St. Jude Medical . The letter was addressed to Cath Lab Manger/ Risk Manager. The letter described the problem and the product involved. Advised consignees to discontinue use of the product and remove from inventory.
Sales Representatives were also sent a St. Jude Medical Memorandum "Field Action Notice" dated June 24, 2010 and a reconciliation form. The memorandum described the problem and product. Advised Sales Rep to visit the affected accounts and to performed the assigned tasks.
A St. Jude Medical sales representative will be contacting for removal and replacement of the affected product. For additional information, please contact St. Jude Medical at 651-491-4470.
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
Introducer, Catheter - Product Code DYB
Causa
Potential for a partial or complete separation of the shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. if either of these were to occur during use, it is likely that fluids would leak around the introducer hub and strain relief.
Acción
Consignees were sent "Urgent Medical Device Recall Notice" dated June 24, 2010 from St. Jude Medical . The letter was addressed to Cath Lab Manger/ Risk Manager. The letter described the problem and the product involved. Advised consignees to discontinue use of the product and remove from inventory.
Sales Representatives were also sent a St. Jude Medical Memorandum "Field Action Notice" dated June 24, 2010 and a reconciliation form. The memorandum described the problem and product. Advised Sales Rep to visit the affected accounts and to performed the assigned tasks.
A St. Jude Medical sales representative will be contacting for removal and replacement of the affected product. For additional information, please contact St. Jude Medical at 651-491-4470.
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
Introducer, Catheter - Product Code DYB
Causa
Potential for a partial or complete separation of the shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. if either of these were to occur during use, it is likely that fluids would leak around the introducer hub and strain relief.
Acción
Consignees were sent "Urgent Medical Device Recall Notice" dated June 24, 2010 from St. Jude Medical . The letter was addressed to Cath Lab Manger/ Risk Manager. The letter described the problem and the product involved. Advised consignees to discontinue use of the product and remove from inventory.
Sales Representatives were also sent a St. Jude Medical Memorandum "Field Action Notice" dated June 24, 2010 and a reconciliation form. The memorandum described the problem and product. Advised Sales Rep to visit the affected accounts and to performed the assigned tasks.
A St. Jude Medical sales representative will be contacting for removal and replacement of the affected product. For additional information, please contact St. Jude Medical at 651-491-4470.
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.
Defective battery was identified as cause for reports of inability to communicate or recharge the product.
Acción
St. Jude Medical sent an "IMPORTANT MEDICAL DEVICE RECALL" letter dated May 24, 2011 to all affected customers. The letter describes the product, problem and actions to be taken by the customers.
St. Jude Medical recommends no action be taken if the product serial numbers do not match the numbers listed in the letter. For product remaining in unimplanted inventory, customers are instructed to contact their SJM representative so that product may be returned and replacements be provided. For implanted product that matches the serial numbers, the Medical Advisory Board recommend not to unnecessarily explant the devices if they are functioning as intended. Replacement devices will be provided at no additional cost to the customer. A Product Reconciliation Form was attached to the letter for customers to complete and return any unused product to the St. Jude Medical Neuromodulation Division at 6901 Preston Road., Plano, TX 75024.
Questions regarding this recall are directed to the customer's St. Jude Medical Neuromodulation Division Representative.
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.
Product programmed with unapproved software was distributed.
Acción
St. Jude Medical Neuromodulation contacted all affected customers by telephone between June 2, 2009 and June 5, 2009. Customers were given information about the product, problem and action to be taken.
All affected devices were returned to the firm as instructed.
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.
St. jude medical cardiovascular division is conducting a voluntary recall of all batches and model numbers of the mitraxs self adjusting atrial retractor. st. jude medical has been distributing this product since their acquisition of clr in late 2008.
they have determined that some distributed batches have very small burrs on the polycarbonate material at the distal edge. as these burrs may.
Acción
The firm, St. Jude Medical, sent an "Urgent Medical Device Recall Notice" dated January 26, 201,1 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to discontinue use of the product (MitraXs Self Adjusting Atrial Retractor batches) and remove from inventory.
St. Jude began production of a new batch of units that will bear the labeling of St. Jude Medical. Shipment of these units started on January 10, 2011. Note: A St. Jude Medical Sales Representative will contact the customer to facilitate removal and reconciliation of the affected product.
If you have any questions or concerns, please contact your St. Jude Medical Sales Representative or 651-490-4470 and/or 612-310-7936.
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
Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
Causa
Analysis of the difference between the actual device longevity and the battery indicator status provided by the clinician programmer (cp) or patient controller (pc) has revealed errors in the cp or pc longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.
Acción
St. Jude Medical sent an Important Medical Device Advisory letter dated September 12, 2017, to all affected customers. Customers were advised the following:
Phase I: ERI Assessment
¿ If a patient reports that an ERI message is displayed on the PC, please contact your Abbott
Representative to obtain the device-specific generator logs and to conduct the ERI Assessment using the
steps in Appendix B prior to making an elective replacement decision.
¿ After the ERI Assessment is completed, follow-up communication from your Abbott representative will
be provided in order to make appropriate decisions. The response will be one of two possible responses:
o ERI is valid at this time for this device, follow existing information provided by IFU and CP for
the elective replacement window for this device.
o The device has the appropriate level of battery voltage to provide the existing therapy until the
next assessment, which should occur no later than March 2018. During this period, the ERI
message will be displayed on the PC at the start of each session. This message may be
dismissed to enter the session on the PC.
Phase II: ERI Software Update
Abbott will deploy a software upgrade, upon approval by local governing agencies that addresses the errors in
calculation causing the inappropriate ERI message. When this software update is deployed, the Phase I ERI
assessment process is no longer needed. After the CP is updated, replacement decisions can be made following
the revised instructions for use, which will be available at manuals.sjm.com. Once approved for use in your
area, notification of the availability of this software update will occur through the Apple¿ Public App Store for
the PC and through the SJM App Catalog for the CP.
Should you have questions about patient management, including questions regarding error messages related to
IPGs, please contact your local Sales Representative or Abbott Support at 1-800-727-7846 (Opt3) (U.S) and
+46 8 474 414
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.
The recall was initiated because st. jude medical made new software available for the sjm confirm dm2100 implantable cardiac monitor (icm) that incorporates enhancements to the devices sensing algorithm. these enhancements are intended to provide improved sensitivity and specificity for diagnosing arrhythmias. the user is presented with the option to upgrade new software into the sjm confirm icm.
Acción
St. Jude Cardiac Rhythm Management Division sent an "Important Product Correction" letter on March 25, 2011 to all affected customers.
The letter explains the reason for the recall and provided recommendations including a software upgrade by SJM Field Clinical Engineer or Technical Services. Customers were recommended to fill out and return a "Physician Acknowledgement Form".
For additional information please contact your local St.Jude Medical Sales Representative, Field Clinical Engineer or the Technical Services Department at 800-722-3774
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.
St. jude medical has received reports of out of range pacing lead impedance (pli) measurements.These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. the out of range readings are concluded as false.
Acción
The firm, St. Jude Medical, sent an "IMPORTANT PRODUCT FIELD CORRECTION" letter dated September 22, 2011 to its customers by FedEx priority overnight service for planned receipt on September 23, 2011. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed that in order to prevent a false reading, a new programmer software version (12.1.0.1) is available. This software when used to interrogate an Accent DR or Anthem CRT-P pacemaker will eliminate the potential for this anomaly to occur. The onetime upgrade is performed automatically on affected devices and will not change the operation of the implanted device. A St. Jude Medical Sales Representative will assist the customers in loading the new programmer software onto their Merlin programmer.
Customers with questions or concerns, can contact their local St. Jude Medical representative or their Technical services department at (800) 722-3774.
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.
St. jude medical has received reports of out of range pacing lead impedance (pli) measurements. these measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. the out of range readings are concluded as false.
Acción
The firm, St. Jude Medical, sent an "IMPORTANT PRODUCT FIELD CORRECTION" letter dated September 22, 2011 to its customers by FedEx priority overnight service for planned receipt on September 23, 2011. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed that in order to prevent a false reading, a new programmer software version (12.1.0.1) is available. This software when used to interrogate an Accent DR or Anthem CRT-P pacemaker will eliminate the potential for this anomaly to occur. The onetime upgrade is performed automatically on affected devices and will not change the operation of the implanted device. A St. Jude Medical Sales Representative will assist the customers in loading the new programmer software onto their Merlin programmer.
Customers with questions or concerns, can contact their local St. Jude Medical representative or their Technical services department at (800) 722-3774.
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.
Eon mini ipgs manufactured in april 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful. sjms routine testing, monitoring, and analysis of manufacturing processes identified three lots of eon mini ipgs that the internal battery has the potential to come into contact with the internal microcontroller board.
Acción
ST. Jude Medical sent an important Medical Device Advisory letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem and recommended actions to be taken. For questions contact your St. Jude Medical Neuromodulation Division Representative or call the Technical Services Department at 1-800-727-7846.
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
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
Causa
St. jude medical cardiovascular and ablation technologies division is performing a voluntary notification regarding selected batched of safire duo ablation catheter mediguide enabled. these units have a cable connector configuration that is different than intended.
Acción
Consignees were sent a St. Jude Medical "Urgent Medical Device Notice" dated 11 October 2013. The letter was addressed to Cath lab manger / Risk Manger. The letter described the problem and the product involved in the recall. The letter stated that it is acceptable to continue using these devices as long as the product is used in accordance with the IFU.
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
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
Causa
St. jude medical cardiovascular and ablation technologies division is performing a voluntary notification regarding selected batches of coolpath duo ablation catheter mediguide enabled products and safire duo ablation catheter mediguide enabled. these units were inadvertently shipped with the incorrect version of the instructions for use (ifu).
Acción
The firm, St. Jude Medical (SJM), sent a "Urgent Medical Device Notice" dated 11 October 2013 to its consignees. The letter described the problem, the product involved in the recall and the actions to be taken. The consignees were instructed to discard the IFU received with the batches and replace it with the IFU received in conjunction with the notification letter. SJM has determined that it is acceptable to continue using these devices as long as the product is used in accordance with the IFU.
If you have any questions, contact Vice President, Quality, at 651-756-5402.
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
Introducer, catheter - Product Code DYB
Causa
St. jude medical is conducting a voluntary recall of smj batch # 4641580 of the fast-cath trio" hemostasis introducer, catalog number 406308. the inner diameter of the 10f dilator is too small, such that the guidewire cannot advance through the device which may result in a procedural delay while another dilator of the desired size is obtained.
Acción
St. Jude Medical sent an Urgent Medical Device Recall Notice dated October 14, 2014, to all affected consignees. The letter described the problem and the product affected by the recall. Advised consignees to discontinue us of the device. A St. Jude Medical sales representative were to contact the consignee in the near future to facilitate removal and reconciliation of the recalled device. Customers with questions were instructed to contact their St. Jude Medical sales Representative.
For questions regarding this recall call 651-756-2295.
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.
St. jude medical is performing a voluntary recall of batch 4671318, model number 401353 of the response fixed curve deca 6f 65cm csl 2/8 catheter. specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (supreme fc quad 5f catheter) within the packaging. to date, no serious injuries have occurred as a result of this issue.
Acción
St. Jude Medical sent an "Urgent Medical Device Recall Notice" letter dated October 7, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Advised customers to discontinue the use of the recalled device and inform them that a St. Jude Medical sales representative will contact them in the near future to facilitate removal and reconciliation of the recalled device. For questions they can contact their St. Jude Medical Sales Representative. For further questions please call (651) 756-2295.
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.
St jude medical is recalling implantable cardiac defibrillator (icd) and cardiac resynchronization
therapy defibrillator (crt-d) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
Acción
St. Jude Medical, Inc., sent a customer letter to all affected customers to inform them that St. Jude Medical recently announced a global medical device advisory for a subset of their company's Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. The letter informs customers that the cause for Premature Battery Depletion is attributed to the formation of lithium clusters within the battery causing a short circuit. There is a possibility that affected devices may lose battery power within days. Thus far, there have been two (2) deaths and ten (10) serious events (fainting) that may have been associated with premature battery depletion. Customers with questions were instructed to contact www.sjm.com/batteryadvisory, (866) 915-5065.
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.
St jude medical is recalling implantable cardiac defibrillator (icd) and cardiac resynchronization
therapy defibrillator (crt-d) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
Acción
St. Jude Medical, Inc., sent a customer letter to all affected customers to inform them that St. Jude Medical recently announced a global medical device advisory for a subset of their company's Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. The letter informs customers that the cause for Premature Battery Depletion is attributed to the formation of lithium clusters within the battery causing a short circuit. There is a possibility that affected devices may lose battery power within days. Thus far, there have been two (2) deaths and ten (10) serious events (fainting) that may have been associated with premature battery depletion. Customers with questions were instructed to contact www.sjm.com/batteryadvisory, (866) 915-5065.
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.
St jude medical is recalling implantable cardiac defibrillator (icd) and cardiac resynchronization
therapy defibrillator (crt-d) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
Acción
St. Jude Medical, Inc., sent a customer letter to all affected customers to inform them that St. Jude Medical recently announced a global medical device advisory for a subset of their company's Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. The letter informs customers that the cause for Premature Battery Depletion is attributed to the formation of lithium clusters within the battery causing a short circuit. There is a possibility that affected devices may lose battery power within days. Thus far, there have been two (2) deaths and ten (10) serious events (fainting) that may have been associated with premature battery depletion. Customers with questions were instructed to contact www.sjm.com/batteryadvisory, (866) 915-5065.
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.
Analysis of the difference between the actual device longevity and the battery indicator status provided by the clinician programmer (cp) or patient controller (pc) has revealed errors in the cp or pc longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.
Acción
St. Jude Medical sent an Important Medical Device Advisory letter dated September 12, 2017, to all affected customers. Customers were advised the following:
Phase I: ERI Assessment
¿ If a patient reports that an ERI message is displayed on the PC, please contact your Abbott
Representative to obtain the device-specific generator logs and to conduct the ERI Assessment using the
steps in Appendix B prior to making an elective replacement decision.
¿ After the ERI Assessment is completed, follow-up communication from your Abbott representative will
be provided in order to make appropriate decisions. The response will be one of two possible responses:
o ERI is valid at this time for this device, follow existing information provided by IFU and CP for
the elective replacement window for this device.
o The device has the appropriate level of battery voltage to provide the existing therapy until the
next assessment, which should occur no later than March 2018. During this period, the ERI
message will be displayed on the PC at the start of each session. This message may be
dismissed to enter the session on the PC.
Phase II: ERI Software Update
Abbott will deploy a software upgrade, upon approval by local governing agencies that addresses the errors in
calculation causing the inappropriate ERI message. When this software update is deployed, the Phase I ERI
assessment process is no longer needed. After the CP is updated, replacement decisions can be made following
the revised instructions for use, which will be available at manuals.sjm.com. Once approved for use in your
area, notification of the availability of this software update will occur through the Apple¿ Public App Store for
the PC and through the SJM App Catalog for the CP.
Should you have questions about patient management, including questions regarding error messages related to
IPGs, please contact your local Sales Representative or Abbott Support at 1-800-727-7846 (Opt3) (U.S) and
+46 8 474 414
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.
Analysis of the difference between the actual device longevity and the battery indicator status provided by the clinician programmer (cp) or patient controller (pc) has revealed errors in the cp or pc longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.
Acción
St. Jude Medical sent an Important Medical Device Advisory letter dated September 12, 2017, to all affected customers. Customers were advised the following:
Phase I: ERI Assessment
¿ If a patient reports that an ERI message is displayed on the PC, please contact your Abbott
Representative to obtain the device-specific generator logs and to conduct the ERI Assessment using the
steps in Appendix B prior to making an elective replacement decision.
¿ After the ERI Assessment is completed, follow-up communication from your Abbott representative will
be provided in order to make appropriate decisions. The response will be one of two possible responses:
o ERI is valid at this time for this device, follow existing information provided by IFU and CP for
the elective replacement window for this device.
o The device has the appropriate level of battery voltage to provide the existing therapy until the
next assessment, which should occur no later than March 2018. During this period, the ERI
message will be displayed on the PC at the start of each session. This message may be
dismissed to enter the session on the PC.
Phase II: ERI Software Update
Abbott will deploy a software upgrade, upon approval by local governing agencies that addresses the errors in
calculation causing the inappropriate ERI message. When this software update is deployed, the Phase I ERI
assessment process is no longer needed. After the CP is updated, replacement decisions can be made following
the revised instructions for use, which will be available at manuals.sjm.com. Once approved for use in your
area, notification of the availability of this software update will occur through the Apple¿ Public App Store for
the PC and through the SJM App Catalog for the CP.
Should you have questions about patient management, including questions regarding error messages related to
IPGs, please contact your local Sales Representative or Abbott Support at 1-800-727-7846 (Opt3) (U.S) and
+46 8 474 414
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
Introducer, Catheter - Product Code DYB
Causa
A lot of product contains a 6f obturator with a hub that is incorrectly marked as 5 instead of the appropriate 6. the obturator is correctly sized (6f) per the labeling on both the sterile bag and shelf carton.
Acción
A letter dated 09/20/05 was sent to all customers explaining the issue and instructed customers that a St. Jude Medical Representative will facilitate in the product removel process. Full credit will be issued.
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.
Vendor-supplied memory chip in a limited number of st. jude medical icds can trigger a temporary loss of pacing function and permanent los of defibrillation support.
Acción
Notification material sent to physicians by FedEx. Acknowledgement of receipt of the notification material will be monitored with this information being fed back to St. Jude Medical CRMD in Sylmar, California. In addition, St Jude Medical issued a press release on October 7, 2005.
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.
Vendor-supplied memory chip in a limited number of st. jude medical icds can trigger a temporary loss of pacing function and permanent los of defibrillation support.
Acción
Notification material sent to physicians by FedEx. Acknowledgement of receipt of the notification material will be monitored with this information being fed back to St. Jude Medical CRMD in Sylmar, California. In addition, St Jude Medical issued a press release on October 7, 2005.