Reported Apr 4, 2018 · Terminated
Proclaim DRG Implantable Pulse Generator, Model Number 3664
St. Jude Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: St. Jude Medical, Inc. · 6901 Preston Rd · Plano, TX · 75024-2508
Is this the product you have?
- Proclaim DRG Implantable Pulse Generator, Model Number 3664
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Lot Number 6499208 Serial Numbers: AVD426.1, AVA922.1 2 Lot Number 6263128 Serial Numbers: AVB119.1, AVD400.1, AVA622.1, AVD431.1, AVE633.1, AVK678.1, AVN837.1 3 Lot Number 6268723 Serial Numbers: AUV770.1, AVW805.1 4 Lot Number 6278155 Serial Number AVK896.1 - Amount recalled
- 17 units
Why it was recalled
The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient over stimulation which created discomfort for the patients.
This product could cause temporary or reversible health problems — stop using it.
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