FDA issues recall of 465,000 St. Jude pacemakers to patch security holes. And as they are embedded within the chests of their users. Anthem, Accent MRI, Accent ST, Assurity, and Allure. Rate response settings too low? Jude Medical Type: Assurity DR PM2260. B1 ECG: C4 Actiology: B1 I am a 65 years old male and it is my second PM. I just read that you have had a Sorin Reply pacemaker, and now you have a St. Jude and are reporting problems when exercising. The issue could be that your Sorin pacemaker.
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- User's Manual St Jude Assurity Pacemaker For Sale
We offer an MR Conditional/MRI Ready pacing system so you can better meet the needs of your patients.
Assurity MRI™ Pacemaker
- Manufacturer Specifications - Assurity MRI PM2272 DDDR, St. Jude Medical Please note: None of the equipment posted for sale on MedWOW.com is owned by MedWOW, should you have any questions regarding a specific item, please direct them to the appropriate seller by making use of the available communication channels on the items page.
- JUDE MEDICAL Assurity DR MRI Pacemaker For Sale - DOTmed Listing #2914968: 'THE WORLD’S SMALLEST, LONGEST-LASTING WIRELESS MRI PACEMAKER. The Assurity MRI™ pacemaker offers premium.
The Assurity MRI pacemaker is conditionally safe for use in the MRI environment when used with MRI Ready leads from Abbott and in accordance to the instructions in the user manual.
- Enables full-body, 1.5T MRI scans when used with Abbott MRI Ready leads; see MRI Scan Parameters—Lead Models.
- The SJM MRI Activator™ Device allows you to enable previously stored MRI settings before an MRI scan without the need for a traditional programmer.
For additional information, including additional MRI scanning information, contraindications and potential adverse events, please refer to the MRI Ready Systems Manual.
Assurity MRI In-Service
Programming MRI Mode
SJM MRI Activator
IMPLANTABLE CARDIAC MONITOR
SJM Confirm™ Implantable Cardiac Monitor
The SJM Confirm™ implantable cardiac monitor (ICM) DM2102 is conditionally safe for use in the MRI environment when used in accordance to the instructions in the user manual. Patients with newly implanted or previously implanted devices can undergo MR scanning when following specific scanning conditions.
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These conditions include:
- Closed bore-cylindrical magnet.
- Static magnetic field strength of 1.5 Tesla (T) only.
- Maximum gradient slew rate 200 T/m/s per axis.
- Whole-body specific absorption rate (SAR) less than or equal to 2.0 W/kg.
- The uninterrupted duration of active scanning (when radio frequency and gradients are on) over the chest during MRI must not exceed 60 minutes.
- Confirmation of absence of other contraindicated implantable devices and/or leads, including abandoned leads, lead extenders and lead adaptors.
In non-clinical testing, the SJM Confirm ICM produced a temperature rise of less than 3°C at a maximum MR system-reported whole-body-averaged SAR of 3.9 W/kg as displayed on the MR scanner console for 60 minutes of MR scanning in a 1.5 T closed-bore MR scanner (manufacturer Philips, model Intera 1.5, software version: 9.5.2).
For additional information, including contraindications and potential adverse events please refer to the SJM Confirm ICM User’s Manual. It is important to read the information in the MRI Procedure section of the user manual before conducting an MRI scan on a patient with an implanted SJM Confirm implantable cardiac monitor.
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
Fortify Assura™ ICD
The Fortify Assura™ ICD allows full-body, 1.5T MRI scans that meet certain scan conditions, when combined with specific lead and lead lengths that are MR Conditional.*
- Meets industry-standard MRI testing requirements
- Capable of full body 1.5T MRI imaging scans
ELLIPSE™ ICD
The Ellipse™ ICD System allows full-body, 1.5T MRI scans* that meet certain scan conditions.
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- Meets industry-standard MRI testing requirements
- Capable of full body 1.5T MRI imaging scans
HEART FAILURE MANAGEMENT RESOURCES
CardioMEMS™ HF System
Non-clinical testing demonstrated that the CardioMEMS™ PA sensor is MR Conditional. A patient with this device can be scanned safely, immediately after implantation under the following conditions:
- Static magnetic field of 1.5 Tesla (T) or 3.0 T.
- Maximum spatial gradient magnetic field of 720 Gauss/cm (7200 mT/m) or less.
In non-clinical testing, the CardioMEMS™ PA sensor produced the temperatures in the table below during MRI performed for 15 minutes of scanning (per pulse sequence) in the 1.5 T/64 MHz* and 3 T/128 MHz* MR systems. These temperature changes will not pose a hazard to the patient under the conditions indicated.
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Table 2. MRI Related Heating
1.5 Tesla | 3 Tesla | |
MR system reported whole body averaged SAR | 2.9 W/kg | 2.9 W/kg |
Calorimetry measured values, whole body averaged SAR | 2.1 W/kg | 2.7 W/kg |
Highest temperature change | 1.9°C | 2.3°C |
MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the sensor. Selecting optimal MR imaging parameters to compensate for the presence of the sensor may be necessary. The maximum artifact size (as seen on the gradient echo pulse sequence) extends approximately 5 mm relative to the size and shape of the sensor.
Table 3. Artifact Information
Pulse sequence | T1-SE | T1-SE | GRE | |
Signal void size | 305 mm2 | 34 mm2 | 645 mm2 | 101 mm2 |
Plane orientation | Parallel | Perpendicular | Parallel | Perpendicular |
MULTIPOINT™ PACING PRODUCTS
St Jude Pacemaker Manual
Quadra Assura MP™ CRT-D and Quartet™ Quadripolar LV Lead
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The Quadra Assura MP™ CRT-D and the Quartet™ Quadripolar LV lead allow full-body, 1.5T MRI scans* that meet certain scan conditions.
User's Manual St Jude Assurity Pacemaker For Sale
- Meet industry-standard MRI testing requirements
- Capable of full body 1.5T MRI imaging scans