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
New cessation of implantations and market recall of the NanostimTM wireless pacemaker, model S1DLCP, manufactured by St. Jude Medical, USA, due to the possibility of battery malfunction and recommendations for the follow-up of implanted patients.
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 about the research carried out by the company for the resumption of implantations of the "Portico ™ transcatheter transcatheter transcatheter aortic valve implantation system", manufactured by St. Jude Medical
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 that certain EllipseTM Implantable Cardioverter Defibrillators (ICDs), manufactured by St. Jude Medical CRMD, USA, can not administer high voltage therapy, so the device must be replaced to patients carrying them.
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
Software update of the NanostimTM wireless pacemaker programmer, model S1DLCP, manufactured by St. Jude Medical, USA (company acquired by Abbott, 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
New temporary cessation of implantation of NanostimTM wireless pacemakers, model S1DLCP, manufactured by St. Jude Medical, 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
Removal from the market of Brio ™ implantable pulse generators, manufactured by St. Jude Medical, USA, due to the possible reduction or loss of therapy, and recommendations for the follow-up of implanted patients.
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
Cessation of implantation, market recall and follow-up of implanted patients with the Fortify ™, FortifyAssura ™, QuadraAssura ™, QuadraAssura MP ™, Unify ™, UnifyAssura ™ and UnifyQuadra ™ defibrillators, manufactured by St. Jude Medical, USA, before May 23, 2015.
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
Software update of Merlin @ Home ™ remote monitoring transmitters, manufactured by St. Jude Medical, USA (company acquired by Abbott, USA), to version 8.2.2 that includes improvements in cybersecurity.
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
Cessation of the use of the implants of the "Portico ™ transcatheter transcatheter aortic valve transfemoral implantation system", manufactured by St. Jude Medical, 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
Possibility of a rise in temperature at the implant site during the charging of the implantable pulse generators "Eon", "Eon Mini" and "Brio", manufactured by St. Jude Medical, 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
Temporary cessation of implantation of NanostimTM wireless pacemakers, model S1DLCP, manufactured by St. Jude Medical, 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
Possibility that certain Defibrillators (ICDs) and implantable pacemakers with radiofrequency (RF) capacity, manufactured by St. Jude Medical CRMD, USA, enter back-up mode when used with the Merlin @ home ™ RF transmitter.
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
Restart of the Clinical Study of Post-Marketing Tracking of the "NanostimTM Wireless Pacemaker", model S1DLCP, manufactured by St. Jude Medical, USA.
Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
Notas adicionales en la data
We recommend immediate replacement of the charger for patients who report or have reported excessive heating during charging: - For other patients, replacement of the charger is suggested at the next visit. - After the replacement, the proper operation of the Eon Mini LE Model 3722 Charger must be confirmed. In case of difficulties with the operation of the Eon Mini Model 3722 Charger, due to the depth of the implant, the patient should continue to use the Mini Model 3721 Eon Charger (eg older charger), following the precautions provided in the July letter of 2012. These precautions are as follows: - If the temperature at the implant site becomes uncomfortable during loading: - Stop the recharge until the discomfort disappears and then continue recharging; - Reposition the antenna over the implant site; - Consider a more frequent and shorter recharge; - If the temperature is still uncomfortable, please contact your doctor, SJM representative, or St. Jude Medical Brazil technicians. - Avoid pressing the antenna between the body and a surface that can retain heat, such as a bed or a chair. - The use of topical anesthetics, balsamic medicine, and / or pain relief adhesives at the implant site before or during loading is not recommended as it may reduce the ability to perceive heat or excessive heating near or at the implant site. - Do not carry the device while sleeping. - Do not consume alcohol immediately before or during loading.
Causa
St. jude medical would like to pass on an "important medical device information" regarding the potential overheating or temperature rise at the location where the generator is positioned during the recharge of the implantable pulse generator for eon mini spinal stimulation. some patients may report a temperature rise at the generator implant site during the recharge of the eon mini stimulation system. in brazil, we only had one reported case that was already solved with the change of the loader.
Acción
Field Action Code Eon Mini 3788 triggered under the responsibility of the company St. Jude Medical Brasil LTDA. Company will make correction in the field.
Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
Notas adicionales en la data
In collaboration with the Medical Advisory Committee of St. Jude Medical, the company recommends: Do not implant affected unused devices. Perform routine follow-up of patients according to standard practice. We have included a "Patient Notification Letter" attached to this letter, so you can provide your patients with information to help them with this event. Prophylactic replacement of the device is NOT recommended because the rates of device replacement complications are greater than the risk rate associated with premature battery depletion due to the short lithium deposits induced (see appendix for selected references ). In the case of an ERI indicator on these devices, it is recommended that they be replaced immediately. At this time, there is no factor, method, or test to identify devices with this form of premature battery depletion near the ERI or to accurately predict the remaining battery life once the ERI appears. Physicians should reaffirm the availability of remote monitoring to avoid or minimize time without device therapy for bradycardia and tachycardia events. Enroll patients on the Merlin.net system using the "Direct Alerts" feature to receive immediate alert notification if the ERI is reached. For patients currently enrolled in Merlin.net, remind them of the importance of using remote monitoring. Review the most recent printing of the programmed parameters (see annex with an example). Make sure that in the "Trigger Alerts When" section that the "Device at ERI" parameter is set to "ON" (the nominal is "ON") for both "Show on FastPath" and "Notify Patient" options. "Device at ERI" is set to OFF, it is recommended that the patient is promptly seen to program this parameter to ON Inform patients that an exchange prompt (ERI) triggers a vibrating alert. the patient's device to determine if an ERI alert has been triggered.Perature premature battery depletion can be identified by remote monitoring showing ERI or advanced battery drainage Perform a test on the patient's vibratory notifier to confirm that it can feel, and acknowledge this alert Patients who can not feel the vibrating alert may not know that your device has run out of battery and / or function capacity Advise the patient to enter contact your clinic immediately if they feel the vibrating alert Face-to-face assessment should be performed to determine the reason for the alert, as other non-critical events can also trigger a vibrating alert.
Causa
High voltage devices (icds and trc-ds) that use lithium-based chemical batteries are subject to the formation of lithium deposits during high voltage charging. depending on your location, lithium deposits may cause a short circuit that could lead to premature battery drainage.
Acción
Field Action Code CDI's triggered under the responsibility of the company St. Jude Medical Brasil LTDA. Company issued Safety Alert informing about possible premature battery depletion associated with CDI if CDI s St. Jude Medical Brazil Resyncers manufactured before May 2015.
Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
Notas adicionales en la data
Information for physicians to manage patients who will receive an implant or who already had an implanted HM3 device: • During the implant, by fitting the Outflow Graft to the Pump Cap, a click sound should be heard while the Screw Ring is being tightened. Continue to rotate the screw ring clockwise until it stops completely and stop making click sound for a tight hand tight connection. • If a low-flow alarm persists at any time after implantation, and other potential causes such as hypertension, low preload, right heart failure, and influx occlusion were considered as cause, computed tomography (CT) angiography should be performed to identify possibility of occlusion of the graft of the graft output. • If surgical repair of the exit graft is necessary due to a torsion occlusion, the flexion relief of the exit graft must be reconnected in its original state or repaired to avoid further folds or occlusion of the graft. Physicians who manage patients who exhibit a persistent low-flow alarm should determine home-based patient care recommendations based on a single clinical case. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 05/04/2018 - Date of notification notice to Anvisa: 04/06/2018 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
This is a guiding action so doctors can manage patients who will receive an implant or who have already had an implanted hm3 device. the company received reports of flow outflow occlusions by twisting the graft in the hearttmate 3 (hm3) left ventricular assist system. as a result, patients whose devices exhibit these flow occlusions will experience a persistent low-flow alarm. graft twisting in the outflow can result in serious adverse events such as hemodynamic compromise, thrombosis and death.
Acción
Field Action Code HM3-04-18 triggered under the responsibility of the company St. Jude Medical Brasil LTDA. Update, correction or complementation of the actions of use.
Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
Notas adicionales en la data
ANVISA through the Technovigilance Unit will monitor all relevant actions. If you have any questions, please contact St. Jude Medical Brazil at (11) 5080-5400, and for event notification associated with the use of the equipment, contact ANVISA - Technovigilance Unit by telephoning 61 - 3448 1485 or by tecnovigilancia@anvisa.gov.br.
Causa
The company st. jude medical has detected a low frequency related to a specific supplier's static random access memory chip used in the following st. jude medical cardiac defibrillators: photon dr (model v-230hv) (certain serial numbers); photon micro vr / dr (models v-194 / v-232); atlas vr / dr (models v-199 / v-240). this anomaly may cause a temporary loss of the stimulation function and permanent loss of the defibrillation support. this occurred because the said memory chip could be affected by the cosmic background radiation that reaches the earth. it is common knowledge that cosmic background radiation constantly bombards the earth. while the earth's atmosphere acts as a shield and absorbs much of this cosmic radiation, some amount of high energy particles hits the earth. st. jude medical has determined that when the static access memory (sram) chip is exposed to background levels of atmospheric ionizing cosmic radiation it can cause a high current drain state, causing the problem described above. according to the company, in brazil, 1028 of these devices were implanted.
Acción
The company forwarded to the doctors responsible for the implantation of these devices in Brazil a letter alerting them to the problem and with instructions on how to proceed, as follows: • "If it is not already part of your current practice, doctors should routinely monitor the device every 3 months for patients with the affected models listed above. "•" In determining whether additional follow-up will be necessary, consider the low failure rate of the anomaly and the unique and individual needs and medical situations of each patient , including whether the patient is pacemaker dependent or is at high risk of life due to arrhythmias. "•" If a patient's device is detected as in Hardware Reser Mode, you should arrange for replacement of the patient as soon as possible. "•" Continue to provide patients with the usual warnings so they do not miss scheduled appointments and report any changes in symptoms. "
Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
Notas adicionales en la data
Since July 2002 around 143,000 CDIS of the EPIC and ATLAS families have been implemented around the world, and around 123000 remain active today. To date, eight devices (among the 143,000) that have lost ventricular sensing have been detected - the risks detrimental to the patient are in the order of 1 in 1 million. The loss of ventricular sensing was attributed to a well-defined but extremely rare timing sequence that occurs in a very short time window (61 microseconds). To date, there have been no reports of injury or death of any patient to St Jude Medical because of the problem cited. According to St. Jude Medical Ltda, a simple software updater of the generator programmer / firmware will solve the problem, being possible, according to information presented by the company, the software update of both implanted equipment and those not yet implemented . For more details, consult the informative letter provided by St. Jude Medical Ltda (http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta900_carta.pdf). The Anvisa Technovigilance Unit is following up on this case. ## Update (09/03/2009): St. Jude Medical Brasil Ltda informed the UTVIG / Anvisa on 03/12/2008 about the completion of the updating process of the mentioned defibrillators this alert.
Causa
Possibility of loss of ventricular sensing in the implantable cardioverter defibrillators (dcis) of the epic and atlas families.
Acción
The company that registers the EPIC and ATLAS cardioverters in Brazil, ST JUDE MEDICAL BRASIL LTDA, started in Brazil an update of the software integrating implantable cardioverter defibrillators (CDIS). Sales teams and clinical field engineers at St. Jude Medical will carry out the software upgrade on the already distributed PCS Merlin and Model 3510 programmers.
Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
Notas adicionales en la data
This security alert can be updated at any time. The company undertakes to keep this Agency informed.
Causa
The company st jude informs that, because of having been a victim of accidents, for the health of the population, the products listed in the annex should not be purchased by clients and health professionals.
Acción
Those who become aware of the offer of related products should contact the company, ensuring the confidentiality of the informant. St. Jude Medical Brazil Tel. 11 5080 5400 Fax 11 5080 5439 aiwakura@sjm.com lector@sjmbrasil.com br.sjm.com
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
According to the report of the manufacturer, during the maintenance of the condenser or during charging for the high-voltage therapy of the active implantable medical device "st. jude medical ellipse vr / dr - implantable cardioverter defibrillator (icd), the message "capacitor charge time limit reached" may appear due to a fault with the high voltage capacitor. this error may delay the delivery of high-voltage therapy or suspend delivery of part or all of the programmed high-voltage shocks. as a result of this error, there were no serious injuries or deaths reported to "st. jude medical. ".
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.