St. Jude Medical Recalls Proclaim DRG Implantable Pulse Generators
St. Jude Medical is recalling 17 Proclaim DRG Implantable Pulse Generators due to error messages during routine checks and transient overstimulation causing patient discomfort.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a defect (transient overstimulation) caused patient discomfort, but no serious injuries or deaths are reported in the source text.
Plain-English summary
St. Jude Medical, Inc. is recalling 17 units of the Proclaim DRG Implantable Pulse Generator, Model Number 3664. The recall involves specific lot and serial numbers distributed in the United States.
The firm initiated the recall after receiving complaints regarding error messages that occurred during routine impedance checks. Some of these complaints were also associated with transient overstimulation, which created discomfort for the patients.
Patients with these specific devices should contact their healthcare provider for further evaluation and instructions.
The recalled product
- Product
- Proclaim DRG Implantable Pulse Generator, Model Number 3664
- Manufacturer
- St. Jude Medical, Inc.
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- AVA214.1
- AVL027.1 Lot Number 6499208 Serial Numbers: AVD426.1
- AVA922.1 Lot Number 6263128 Serial Numbers: AVB119.1
- AVD400.1
- AVA622.1
- AVD431.1
- AVE633.1
- AVK678.1
- AVN837.1 Lot Number 6268723 Serial Numbers: AUV770.1
- AVW805.1 Lot Number 6278155 Serial Number AVK896.1
Distribution
Distribution scope not specified by the agency.
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