Emblem (defibrillators)

2020: Notification of 87,000 defective devices

In mid-December 2020, Boston Scientific warned medical professionals about 87 thousand defective cardioverter defibrillators Emblem S-ICD. According to the company, patients with subcutaneous ICD may require early revision surgery due to premature battery discharge.

According to the verification data, Emblem S-ICD A209 and A219 devices contain a low voltage capacitor, which can lead to too fast battery discharge. The company's analysis of the returned devices shows that at least three months are left before the battery is discharged. The problem does not affect models released after August 2018, because from this period Boston Scientific began to use another low-voltage capacitor. According to the company, serious injuries or deaths in connection with this problem have not yet been noted.

Boston Scientific warned of 87 thousand defibrillators defected subcutaneous

In total, Boston Scientific issued three notifications about the problems of its defibrillators. In a second notification, doctors warned of a possible marriage of approximately 47,000 Emblem S-ICD1 subcutaneous electrodes (Model 3501). Boston Scientific said it has received 27 reports of damaged electrodes since 2017. Production scrap may cause the defibrillator force to be out of tune. Due to electrode problems, one patient died.

In its third report, Boston Scientific notified physicians that 3,350 Emblem S-ICD A209 and A219 devices may exhibit electrical overvoltage during high-voltage therapy. This is due to industrial marriage, as a result of which water can enter the device, which causes a short circuit during treatment. Boston Scientific has confirmed six cases of electrical overvoltage. There were no reports of serious injuries.^[1]

2019: Withdrawal of defective devices

At the end of August 2019, Boston Scientific recalled a group of defective subcutaneous implantable defibrillator cardioverters (ICD) that discharge too quickly.

The company said the problem affects about 400 (0.7%) ICD models Emblem S-ICD and Emblem MRI S-ICD. As indicated in the warning, these devices have an "increased probability (19% in 3 years) of accelerated battery discharge due to a defective electrical component." Boston Scientific assures that all defective devices were manufactured in July 2017 and are no longer on sale.

Boston Scientific recalls defective subcutaneous defibrillators that discharge rapidly

Such a marriage can be detected during a regular inspection of the device: a doctor may suspect a threat due to an unexpected decrease in battery capacity, or thanks to an indicator of premature replacement or battery condition. The potential danger of defective ICDs is for about 1 patient out of 20,000 people in three years.

The potential danger to the lives of all other patients who use the devices of this model produced at other times threatens about 1 person out of 5,000,000 in three years.

Basically, Boston Scientific recommends simply replacing the device with a previously agreed one; serious injuries and side effects due to this defect have not yet been observed, since the problem can be easily detected. In case of a timely decrease in battery capacity, the devices can ensure uninterrupted operation for 21 days before the planned replacement of the PCD.

Boston Scientific recommends that doctors register patients with ICD data with the Latitude NXT remote monitoring program and perform device checks every three months. Also, with a decrease in battery charge or high-risk patients, it is recommended to plan to replace the ICD within 21 days.^[2]

Notes