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August 11,MedtronicCurrently in the United StatesRecall 22,110Platform Cobaltand Crome Implantable Cardioverter Defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D）
Its basis FDAData,Class I Recall - FDA The Most Severe Classification- It is due to the Cobalt and Crome ICD and CRT-D.Impact energy may be reduced during high-pressure treatment.. While some devices only offer approximately79% of Programming EnergyMedtronic estimates the efficacy of its devicesDecreased by 1%。
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Medtronic Recalls Over 20,000 Devices
Cobalt and Crome ICD and CRT-D
It is reported that this recall involves 22,110 Cobalt and Crome Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D). The U.S. FDA has classified it as a Class I recall. This software was released by Medtronic.In June, an urgent field safety notice was also issued in Europe, warning of the same issue. Medtronic stated that it does not recommend replacing the implanted devices.. The software update is expected to address issues in both new and existing implants. Medtronic has requested hospitals to return certain non-implant devices for inspection.
Medtronic Cobalt and Crome ICD [Image courtesy of Medtronic]
Claim that during high-voltage (HV) therapy in Cobalt and Crome implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D), there is a possibility of reduced shock energy (approximately 79% of programmed energy).The Short Circuit Protection (SCP) alarm is triggered during the first or second phase of HV biphasic waveform delivery while HV therapy is being administered.
This communication focuses on the second phase of the SCP event, which results from the detection of a secondary, low-level current path in the HV circuit. The second phase SCP event will deliver approximately 79% of the programmed energy in the form of a monophasic waveform.Considering the cumulative success rate of the entire series of shocks (Rx1 to Rx6), the defibrillation efficacy for such SCP events decreases by approximately 1% when HV therapy is programmed to 40J.
Later, based on the analysis of peer-reviewed literature and overCareLink Data on 279,000 Shocks (Table Above) Estimates the Termination Success Rate of 32J (Approximately 79% of 40J), Monophasic Shocks vs. 40J Biphasic Shocks. The success rate of termination may vary depending on the risk factors and medication usage of individual patients.
Although it has been observed to be 0.03% so far,But Medtronic estimates that approximately 0.18% of 80,000 distributed devices may experience a second-phase SCP event within 24 months of their service life., considering that the probability of these SCP events increases over time, and the patient may require HV treatment during this period.For the patient population receiving HV therapy, the observed rate is 0.77%. When predicting for this population, the probability of encountering a second-stage SCP event at 24 months is approximately 5.0%.
As of June 3, 2022, Medtronic has identified 27 devices (0.03% of globally distributed devices) that have experienced reduced energy shocks accompanied by a Short Circuit Protection (SCP) alarm.Medtronic has not received any reports of permanent injury or death caused by this issue.
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Previously 21 years of similar equipment
Recall Involves 200,000 Units
It was reported earlier that21 Years, Medtronic in ChinaICDSandCRT-D AnotherClass I RecallInvolved239,171 unitsDevices, which may have battery life issues (battery drain problems), are related to over 400 complaints associated with Medtronic's Evera, Viva, Brava, Claria, Amplia, Compia, and Visia devices.
ItsClaimed that among 264 medical device reports, 18 people were injured, including those with symptoms of bradycardia (slow heart rate) or heart failure.. No deaths have been reported. The issues with these devices involve potential short circuits, which could lead to an unexpectedly rapid depletion of battery life. From the first "Recommended Replacement Time" warning toThe time between complete battery depletion may be as short as one day.However, a Medtronic spokesperson pointed out to MassDevice that the median time from RRT to service termination was 14 days.
Medtronic stated that it will no longer distribute the battery design related to this issue.Since February 2019, no ICD and CRT-D implants have been affected by this issue.. Subsequently, on February 3 of the same year, an urgent medical device correction letter was sent to all affected healthcare providers.
Later, this medical device giant told doctors to continue normal follow-ups according to local clinical protocols.Including reminding patients to contact their clinic when they hear an audible alert and taking advantage of the CareLink home monitoring system and wireless low battery voltage CareAlert whenever possible.If an unexpected Recommended Replacement Time (RRT) warning is observed, the device needs to be replaced immediately.
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Medtronic Responds to Recall Incident
Its Software Version Update
Medtronic later stated that as of August 5, 2022, Medtronic had confirmed inOf the approximately 89,500 devices distributed globally (with an observation rate of 0.05%), 41 devices experienced a Phase Two SCP event.For devices without the software update, the rate remains within the projected rate expected to occur over 24 months. Medtronic has not received any reports of permanent harm or death caused by this issue.
Since August 10, 2022,Software Version Now Available for CareLink™ SmartSync™ Device Manager (SmartSync). Use software application D00U005 version 7.1.1 (or higher)After Updating the SmartSync Tablet, programmers will deploy device updates for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds)., to prevent intermittent second-stage short circuit protection (SCP) events that may occur during the implementation of high voltage (HV) therapy.。
Medtronic representatives can collaborate with clinicians to ensure that all SmartSync tablets in their facilities are using the application software.D00U005 Version 7.1.1 (or higher)Perform updates. The software can update eachSmartSync tablet connects to the internet, opens the SmartSync application, and follows the on-screen prompts to install.。
As disclosed in the June 2022 patient management recommendations, patients will need to visit the clinic to have the update installed on their device by using the updated SmartSync tablet.After installation, the update will allow the device to deliver full programmed shock energy. Programming of the B>AX pathway and Active Can is still required.. The on-screen messages will reinforce these programming recommendations. Additionally, if a low-level current path occurs in the HV circuit, this programming can reduce the theoretical risk of arrhythmia.
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So, with MedtronicCobalt and Crome Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) are being recalled successively. What kind of market reshuffle will Medtronic's defibrillator market face?Can domestic brands fill the gap during this period, accelerate the layout of overseas markets, and increase their share in the global ventilator market?In this regard, Device Home will continue to follow up.