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: boston scientific wingspan™ stent system with gateway™ pta balloon catheter
medical device manufacturer, boston scientific, has issued an urgent field notice on wingspan™ stent system and gateway™ pta balloon catheter.
the manufacturer has revised the intended use in the indication for use of the device. the revised intended use of the device is as follows:
the wingspan stent system and gateway pta balloon catheter indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels >=50% stenosis that are accessible by the system.
according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.
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: soloist™ single needle electrode
medical device manufacturer, boston scientific, has issued a field safety notice concerning certain lots of soloist™ single needle electrode.
according to boston scientific, an internal review showed that certain lots of the products were labeled with incorrect expiration dates, in which the expiration date labeled on the electrode (20 years) and the outer box (5 years) was greater than the acceptable 3 year expiration date. no injury is reasonably expected because all affected lots of the product are still within the 3 year expiration date. the manufacturer advised to immediately discontinue use of the affected products.
according to the local supplier, the affected products have not been distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
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: boston scientific imager™ ii catheter (urology)
medical device manufacturer, boston scientific, has issued a field safety notice concerning imager ii™ catheter (urology).
boston scientific has found that, during shipping, some units in the 5-pack box may experience a physical interaction between the carton and the area on the pouch where the hub is located. this interaction was found to cause pinholes in the sterile barrier pouch of affected products. the investigation found that these pinholes are not likely to be detected by visual inspection. 13 complaints have been received from imager pouch damage issues and no adverse health consequence is reasonably expected to occur from these pinholes.
according to the local supplier, the affected product is not distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
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
Medical device safety alert: conmed stat 2 flow controller
the u.S. food and drug administration (fda) posted a medical device safety alert concerning stat 2 flow controller, manufactured by conmed.
the affected products may deliver a significantly higher flow rate than was intended. the manufacturer is recalling the conmed stat 2 flow controller
for details, please refer to the fda website http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id=69088&w=10012014〈=eng
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 3 october 2014.
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: boston scientific imager ii™ angiographic catheter (peripheral intervention)
medical device manufacturer, boston scientific, has issued a field safety notice concerning imager ii™ angiographic catheter (peripheral intervention).
boston scientific found that, during shipping, some units in the 5-pack box may experience a physical interaction between the carton and the area on the pouch where the hub is located. this interaction was found to cause pinholes in the sterile barrier pouch of affected products. the investigation found that these pinholes are not likely to be detected by visual inspection. 13 complaints have been received from imager pouch damage issues and no adverse health consequence is reasonably expected to occur from these pinholes.
according to the local supplier, the affected products were distributed to hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
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
Medical device safety alert: boston scientific encore 26 advantage kit
medical device manufacturer, boston scientific, has issued a medical device safety alert concerning encore 26 advantage kit [catalogue no.: 04527-01, 04527-05]
the manufacturer has discovered that users of the encore 26 advantage kits which were manufactured between 3 aug 2012 and 18 sep 2012 may experience difficulty in passing guidewires through the insertion tool which is included with encore 26 advantage kits. the difficulty to pass guidewires, especially j-tipped guidewires, through the insertion tool is caused by a lack of smoothness within the hub/hypo tube transition in some devices. this issue may lead to a clinically insignificant prolongation of the procedure upon attempt to insert a guidewire into the insertion tool but it not expected to cause increased risk of injury.
according to the local supplier, the affected products were not distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 17 october 2012.
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
Medical device safety alert: boston scientific subcutaneous implantable defibrillator system
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning the subcutaneous implantable defibrillator system, manufactured by boston scientific.
according to the manufacturer, a rare condition in which an internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. the fuse has been unintentionally activated once during an implant procedure and three times post-implant out of approximately 1,900 devices implanted worldwide. all three post-implant events occurred within one month of implant. the defibrillator may not be able to deliver therapy or communicate with the q-tech model 2020 programmer, and may be unable to emit tones or otherwise respond to magnet application. no patient deaths or injuries have been reported as a result of this behavior.
a non-invasive, software-based mitigation (version 1.95.0) has been developed to protect the fuse from unintended activation. local sales representative will install this new software on all q-tech model 2020 programmers located at the hospital/clinic.
furthermore, the manufacturer has the following recommendations for healthcare professionals:
for patients whose device has been implanted for less than three months, it is recommended to schedule a follow-up visit as soon as possible within the next six weeks
for patients whose device has been implanted for three months or more, ensure the next scheduled visit occurs within three months of the previous visit, as recommended in device labeling
at the next follow-up visit, interrogate each patient’s device using a programmer with version 1.95.0 software. interrogation with an updated programmer will automatically add the new software to the implanted device.
according to the local supplier, the affected products were not distributed in hong kong.
for details, please refer to mhra website
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/
fieldsafetynotices/con244550
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 12 march 2013.
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
Medical device safety alert: boston scientific nephromax high pressure nephrostomy balloon catheter and nephromax high pressure nephrostomy balloon catheter kit
medical device manufacturer, boston scientific, has issued a field safety notice concerning nephromax high pressure nephrostomy balloon catheter and nephromax high pressure nephrostomy balloon catheter kit.
boston scientific is conducting a recall removal of six batches of the nephromax high pressure nephrostomy balloon catheters and three batches of the nephromax high pressure nephrostomy balloon catheter kits (which are packaged with an encore 26 inflator). boston scientific has discovered that the product which is labeled to contain either a 30f x 20cm or a 24f x 17cm renal sheath may potentially contain the incorrect renal sheath size in the package. there have been five complaints received from a single batch for this issue where the product was labeled to contain a 30f x 20cm sheath but actually contained a 24f x 17cm sheath.
boston scientific is aware that customers may separate the kits and store the components individually. therefore, the manufacturer advises users that when reviewing inventory, they should look for both the kit level and individual component level batch numbers. furthermore, the manufacturer advises users to immediately discontinue use of and segregate affected products, and to return the affected product.
according to the local supplier, affected products were not distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 31 may 2013.
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
Medical device safety alert: boston scientific alair bronchial thermoplasty catheter
medical device manufacturer, boston scientific, has issued a field safety notice concerning alair bronchial thermoplasty catheter with:
material no.: m005ats25010
catalogue no.: ats 2-5
lot/batch no.: cm040212
expiration date: apr 2014
according to boston scientific, it has discovered an inconsistent “use by” expiration date on a single lot/batch of alair bronchial thermoplasty catheters. the expiration date is listed in two locations on the packaging of the product; the outer box label and the inner tray label. the expiration date on the outer box label, 2014-04, is correct. however, the expiration date on the inner tray, 2012-04, is incorrect. the actual product expiration date is 2 years beyond the incorrect date on the inner tray label. there is no patient risk related to the incorrect date on the inner tray label since the product is not actually expired.
the manufacturer advises users that they can continue to use the device until the expiration date on the outer box label, 20 14-04.
according to the local supplier, affected products were not distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 31 may 2013.
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
Medical device safety alert: boston scientific rigiflex ii single use achalasia balloon dilator
medical device manufacturer, boston scientific, has issued a field safety notice concerning rigiflex ii single use achalasia balloon dilator with:
material no.: m00554510
catalogue no.: 5451
lot/batch no.: 091541
expiration date: 2013-12
boston scientific has become aware that the pouch label expiration date on a single lot/batch of rigiflex ii single use achalasia balloon dilators is labeled with the incorrect expiration date, 0213-12. boston scientific has confirmed that the correct expiration date is 2013-12 (in the year-month format, yyyy-mm). the product is not expired and there is no patient risk related to the labeling issue if the product is used prior to 2013-12.
the manufacturer advises users to immediately discontinue use of and segregate affected products, and to return the affected product.
according to the local supplier, affected products were not distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 31 may 2013.
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
Medical device safety alert: boston scientific 4mm x 15mm small peripheral cutting balloon (monorail and over-the-wire) microsurgical dilatation device, and 4mm x 15mm flextome cutting balloon (monorail and over-the-wire) microsurgical dilatation device
medical device manufacturer, boston scientific, has issued a field safety notice concerning 4mm x 15mm small peripheral cutting balloon (monorail and over-the-wire) microsurgical dilatation device, and 4mm x 15mm flextome cutting balloon (monorail and over-the-wire) microsurgical dilatation device. the expiration date range from 16 november 2015 to 03 june 2016.
users may experience significant difficulty or inability to remove protector cap from device which may result in damage to the device. boston scientific has received 45 complaints related to this issue from april 2013 to current date, none of which have resulted in patient injury and no additional risk to the patient is expected to occur as a result of this issue.
according to the manufacturer, further distribution or use of affected products should cease immediately. users should segregate and return affected products to boston scientific.
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.
posted on 1 august 2013.
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
Medicalmedical device safety alert: boston scientific cognis crt-ds and teligen icds
medical device manufacturer, boston scientific, has issued a field safety notice concerning cognis cardiac resynchronization therapy defibrillators (crt-ds) and teligen implantable cardioverter-defibrillators (icds) manufactured prior to december 2009. the affected model numbers are as follows:
cognis crt-d: n106, n107, n118, n119, p106, p107
teligen dr icd: e110, f110
teligen vr icd: e012, f102
boston scientific has identified a low voltage (lv) capacitor component that, in some devices, may experience diminished performance after two or more years of implant time. this can increase battery use and eventually trigger one or more safety architecture alerts, accompanied by patient-audible beeping. all cases reported to date have been detected by diagnostic tools within boston scientific’s safety architecture before device function was compromised.
“safety architecture” refers to a set of diagnostic monitoring tools in cognis and teligen designed to mitigate potential device performance and clinical risks. these tools periodically assess device performance, including battery voltage, power consumption, and charge time, and have proven effective in identifying instances of unexpected battery use (via programmer alert screens or replacement indicators) before therapy becomes unavailable.
a total of approximately 264,000 cognis and teligen defibrillators have been distributed and implanted since may of 2008. however, a subset of ~38,500 devices (15% of the total) that were manufactured prior to december 2009 has experienced a higher number of lv capacitor malfunctions (approximately 0.67% or 1 in 150).
boston scientific advises that there are no additional clinical recommendations beyond the current standard of patient care and normal device monitoring, which are described in device labeling. in addition, the manufacturer recommends physicians to call technical services when investigating a safety architecture alert. following a safety architecture alert or explant indicator due to diminished low voltage capacitor performance, the normal 3-month replacement window may be shortened and increased current drain could deplete the battery and compromise therapy/telemetry. technical services can help estimate how much time is available to replace the device, should a low voltage alert or explant indicator occur.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 30 august 2013.
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
Medical device safety alert: boston scientific extractor pro xl retrieval balloon catheter
medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its extractor pro xl retrieval balloon catheter. the material numbers (upn) of the affected products with expiration date of 31 july 2015 are as follows:
m00547100 (with catalogue no.: 4710 and lot no.: 16231178)
m00547110 (with catalogue no.: 4711 and lot no.: 16231174)
m00547140 (with catalogue no.: 4714 and lot no.: 16230354)
the manufacturer is initiating this medical device recall for three lots of the extractor pro xl retrieval balloon catheter device. the manufacturer has become aware that these three lots may be labeled with an incorrect balloon size and/ or skive injection location. if the extractor device is smaller than the included syringe, balloon burst may occur and air may be released or a balloon fragment could be released which could pass naturally through the gi tract or be retrieved. if the extractor device is larger than the included syringe, the balloon under-inflation may occur, and no injury would be expected. if the skive location is above or below where labeled, then the user will see contrast emerge from the other location but still within the lumen.
according to the local supplier, the affected products were not distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 23 december 2013.
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
Medical device safety alert: boston scientific atlantis pv 15 mhz peripheral imaging catheter
medical device manufacturer, boston scientific, has issued a medical device safety alert concerning atlantis pv 15 mhz peripheral imaging catheter. details of affected products are as follows:
material number (upn): h749364560
catalogue number: 36456
lot numbers: 16159358, 16183964, 16230195, 16230673, 16247263, 16257809, 16268498, 16289177, 16311356, 16330543, 16342824, 16419885, 16420624, 16420903, 16447744, 16458536, 16486133, 16494530
expiration date: 11 jun 2014 to 29 oct 2014
the manufacturer has become aware that the manifold of certain lots may be blocked by excess bonding adhesive. a blocked manifold may prevent affected catheter from advancing over the guidewire resulting in a delay in procedure while the device is exchanged for another unit.
the manufacturer advises users to discontinue the use of and segregate the recalled product immediately. the product should be returned to the manufacturer for replacement.
according to the local supplier, the affected products were not distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 17january2014.
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
Medical device safety alert: boston scientific coyote over-the-wire pta balloon dilatation catheter and monorail pta balloon dilatation catheter
medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its coyote over-the-wire pta balloon dilatation catheter and monorail pta balloon dilatation catheter.
the manufacturer is initiating a recall removal of one lot of the coyote over-the-wire pta balloon dilatation catheter [catalog no.: 39186-25121; lot 16397693] and one lot of the coyote monorail pta balloon dilatation catheter [catalog no.: 39185-20151; lot 16310947]. the manufacturer has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. to date, the manufacturer has received three complaints for this issue.
according to the manufacturer, the most common adverse health consequences resulting from a balloon deflation failure is minor vessel trauma without the need for further intervention.
the manufacturer instructs all affected users to cease immediately further distribution or use of any remaining product affected by this medical device safety alert.
according to the local supplier, the affected products were not distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 06 february 2014.
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
Medical device safety alert: boston scientific intellatip mifi xp temperature ablation catheter
medical device manufacturer, boston scientific, has issued a medical device safety alert concerning certain lots of the intellatip mifi xp temperature ablation catheter. the affected catalogue numbers are pm4500, pm4500k2, pm4500n4, pm4790, pm4790k2 and pm4790n4.
an investigation has found that some of the units manufactured from 14 august 2013 to 16 january 2014 were not manufactured according to specification. although this issue will typically result in an error code on the maestro 3000 cadiac ablation system, under certain conditions or in the event of an error code override, this manufacturing issue may result in excessive radio frequency energy being delivered to the myocardium. to date, the manufacturer has received five complaints related to this issue and none of these complaints reported injury.
the potential health hazards associated with the delivery of excessive radio frequency energy include myocardial perforation and cardiac tamponade, as well as char formation on the catheter tip, which may result in embolic injury. the manufacturer advises users not to use the affected products and these products should be returned.
according to the local supplier, the affected products were not distributed to hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 21 may 2014.
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
Medical device safety alert: boston scientific offroad re-entry catheter system
medical device manufacturer, boston scientific, has issued a field safety notice (fsn) concerning its offroad re-entry catheter system, with the following details:
material no.: h74939202070540
catalog no.: 39202-100540
lot no.: 16949014 (expiration date on outer carton: may 2017); 16805826 (expiration date on outer carton: march 2017); 16514008 (expiration date on outer carton: november 2016); 16514006 (expiration date on outer carton: november 2016); 16548224 (expiration date on outer carton: october 2016)
the offroad re-entry catheter system consists of two components, which are contained in an outer carton: the offroad positioning balloon catheter and the offroad micro-catheter lancet. the manufacturer has become aware that the outer package carton for these five lots displays an incorrect expiration date that is two months past the actual expiration date. the actual expiration of the individual positioning balloon catheter and micro-catheter lancet contained within the outer carton is correctly displayed on the pouch and box labels of those components. no adverse health consequence is expected to occur from this issue. the manufacturer has not received any complaints for the incorrect expiration date. affected users are advised to immediately discontinue use of, segregate and return affected products.
according to the local supplier, the affected products were not distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 11 sep 2014.
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
Medical device safety alert: boston scientific autogen dr icds and crt-ds
medical device manufacturer, boston scientific, has issued a field safety notice concerning its autogen dr icds and crt-ds. the affected model numbers for autogen crt-d are g172, g173, g175, g177 and g179. the affected model numbers for autogen dr icd d046, d047, d176 and d177.
according to the manufacturer, the concerned devices include the option of enabling a right ventricular automatic threshold (rvat) test to determine the rv pacing threshold and adjust amplitude in an ambulatory setting. if the rvat test feature is enabled and noise signals are continuously sensed within a brief rv noise window following an atrial pace, a patient may not receive effective pacing support until the rvat test ends (i.E., up to 20 cardiac cycles). although no patients have been harmed in the cases reported to date, brief periods of dizziness were reported in one case. there is no additional risk for patients in whom the rvat feature is disabled.
the manufacturer is developing a software solution that will prevent this device behaviour from occurring when the rvat test feature is enabled. the software solution will be implemented via a non-invasive download from the programmer.
until a software solution can be implemented, the manufacturer recommends the following:
for ambulatory rvat tests, the manufacturer recommends that the rvat test feature is not enabled in autogen dr icds and crt-ds, due to the potential risk of asystole occurring during the rvat test. if the ambulatory rvat test feature has been enabled, the manufacturer recommends disabling the rvat feature at the first opportunity, but within three months.
for in-clinic/commanded rvat tests, the manufacturer recommends that physicians test thresholds manually, rather than utilising the automatic rvat test.
according to the local supplier, boston scientific hong kong limited, the affected products were distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 18 november 2014.
Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), 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 Singapore.