Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Press release
Causa
Safety information regarding st. jude medical implantable cardioverter defibrillators
10 october 2005
the department of health was notified today by the manufacturer of several older generation implantable cardioverter defibrillators that some of its products may be affected by cosmic rays and may not function properly.
according to st. jude medical (hong kong) ltd., the affected models are:
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)
no serious patient injury or death has been reported so far.
there are totally 34 patients implanted with the affected devices through the public hospitals in hong kong. the supplier has advised the hospital authority of this matter. all the affected patients will be informed by their doctors for follow up actions shortly.
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. "
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.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Press release
Causa
Software problem found in programming devices for implantable pacemakers
the department of health received notification from a medical device manufacturing company about a software problem in two programming devices used by doctors for checking the battery level of pacemakers.
the programming devices concerned, produced by st. jude medical inc., are aps iii model 3500/3510 programming devices (software versions 6.1.1 and earlier) and merlin pcs model 3650 programming devices (software versions 4.1.1 and earlier). they are specially designed and made to measure the battery level of the following three pacemaker models manufactured by the same company -
identity sr model 5172
identity dr model 5370
identity xl dr model 5376
a spokesman for dh said the software problem may lead to incorrect reporting of battery voltage, expected battery lifespan of the pacemakers and early replacement indicator in the devices. the details can be found at the corporate website of st. jude medical, inc. at www.Sjm.Com .
dh has alerted the hospital authority, private hospitals and other relevant medical professional organisations of this safety information.
no patient injury or death has been reported so far.
the spokesman said patients shall call the hotlines of st. jude medical ( hong kong ) ltd at 2996 7688 from 9 am to 6 pm from monday to friday for enquiries. they can call 9666 4545 or 9777 0097 outside office hours.
he reminded patients with these implanted pacemakers to attend scheduled regular check-ups arranged with their doctors. if they have any symptoms of heart disease, they should seek medical attention immediately.
end/thursday, october 19, 2006
nnnn.
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.
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.
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.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Press release
Causa
Software defect causes malfunction in implantable cardioverter-defibrillator the department of health (dh) today (may 6) received notification from st. jude medical (hong kong) ltd., a local branch of a multi-national company, about a software problem in its convert+ model v-195 implantable cardioverter-defibrillator (icd).
the model, if programmed by a merlin pcs programmer running version 7.2.1, version 8.2.1 or version 10.2.0 software, may not deliver therapy under certain circumstances. the defect can be corrected. st jude medical recommends doctors who have programmed a patient's device with any of the affected software versions should schedule a follow-up visit to perform the correction recommended by it.
according to st. jude medical (hong kong) ltd., one patient has been implanted with this model of icd in hong kong. however, the implanted device has not been programmed with the affected software version. this model of icd ceased to be sold by the company in hong kong since mid-2007.
no patient injury or death has been reported worldwide.
patients may call st. jude medical (hong kong) ltd. at 9682 0488 for further details.
a dh spokesman reminded patients with implanted icds that they should seek medical attention immediately if they felt unwell.
meanwhile, the dh has informed both public and private hospitals, and relevant medical associations of the issue, and will also follow up with st. jude medical (hong kong) ltd. on further development, if any.
end/thursday, may 6, 2010.
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.
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
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.
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
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.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Field safety notice: st. jude medical quicksite® and quickflex® left ventricular crt leads [models 1056t, 1058t, 1156t and 1158t]
medical device manufacturer, st. jude medical, initiated a field safety corrective action concerning the quicksite® and quickflex® left ventricular crt leads [models 1056t, 1058t, 1156t and 1158t].
according to the manufacturer, the affected devices are designed for use in combination with a compatible pulse generator to provide long-term stimulation and sensing of the left ventricle via the great cardiac vein or one of its tributaries.
the manufacturer had found 39 confirmed cases of externalized conductor. it was estimated that 3-4% of quicksite® and quickflex® leads may exhibit the anomaly. there were no reports of death or serious injury associated with externalized conductor.
according to the manufacturer, if externalization of the cable conductor were to occur, the etfe coating on the cables is designed to provide adequate dielectric strength for the lead to continue to function normally without the silicone covering. the system also provides for multiple alternative pacing configurations that can be programmed, if needed. although no electrical dysfunction attributable to these external conductors has been observed to date, in the case that all of these redundancies were to fail, the inability of the lv crt lead to pace could affect biventricular pacing and result in exacerbation of heart failure.
the manufacturer recommended physicians to continue to monitor their patient’s implanted system at regularly scheduled intervals with attention paid to diagnostic information related to lv pacing performance, in particular lv lead impedance and capture thresholds. in addition, programming of alerts that monitor lead impedance changes outside of the nominal range and enabling the patient notifier should be considered.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.