Abbott's Proclaim™ SCS/Proclaim™ DRG/Infinity™ DBS Implantable Pulse Generators
Brand(s)
Last updated
Summary
Product
Abbott's Proclaim™ SCS/Proclaim™ DRG/Infinity™ DBS Implantable Pulse Generators
Issue
Medical devices - Device compatibility
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Infinity™ 5 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 6660 |
| Infinity™ 5 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 6661 |
| Proclaim™ XR 5 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 3660 |
| Proclaim™ XR 7 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 3662 |
| Proclaim™ 5 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 3665 |
| Proclaim™ 5 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 3661 |
| Proclaim™ 7 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 3667 |
| Proclaim™ 7 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 3663 |
| Proclaim™ DRG Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 3664 |
| Infinity™ 7 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 6663 |
| Infinity™ 7 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 6662 |
Issue
Abbott is sharing important information regarding the Infinity™ Deep Brain Stimulation (DBS) Neurostimulation System, Proclaim™ Spinal Cord Stimulation (SCS) and Proclaim™ Dorsal Root Ganglion (DRG) Neurostimulation Systems. The purpose of this communication is to remind health care providers that the systems contain a Surgery Mode feature designed to help protect the implanted device from potential interference associated with the use of electrosurgical units (ESUs) during certain surgical procedures.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Health products - Medical devices - Anaesthesiology
Companies
Abbott Medical
6901 Preston Road, Plano, Texas, United States, 75024
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81998
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