Proclaim Plus 7 Implantable Pulse Generator Cannot Exit MRI Mode
Abbott Medical recalled Proclaim Plus 7 Implantable Pulse Generators due to a defect preventing patients from exiting MRI mode. This operational failure could compromise device functionality during or after magnetic resonance imaging procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which by definition indicates the potential for serious adverse health consequences. The device malfunction could prevent proper MRI imaging or impair pain management therapy delivery. No illnesses or injuries have been reported in the source.
Plain-English summary
Abbott Medical recalled the Proclaim Plus 7 Implantable Pulse Generator (Model 3672), an electronic device used for spinal cord stimulation therapy. The device is powered by a rechargeable battery and communicates wirelessly with system programmers to deliver electrical stimulation for pain management.
Patients have reported that their devices cannot exit MRI (Magnetic Resonance Imaging) mode once activated. This operational defect means the device remains stuck in MRI mode and cannot return to normal function, potentially compromising device operation and therapy delivery.
In the United States, 387 units of this device were distributed. Worldwide distribution included devices sent to over 40 countries. The FDA classified this as a Class I recall, indicating the serious nature of the safety hazard.
Patients with affected Proclaim Plus 7 devices should contact Abbott Medical or their healthcare provider immediately. Do not attempt to resolve this issue independently. Patients requiring MRI should discuss with their physician whether to proceed with imaging, explore alternative diagnostic methods, or consider device replacement options.
The recalled product
- Product
- Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery w
- Manufacturer
- Abbott Medical
- Hazard
- device-malfunction
- mri-fault
Distribution
Distributed nationwide across the United States.
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