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Recall Observatory FDA recall evidence

Device product

Proclaim DRG Implantable Pulse Generator, Model Number 3664

Z-1170-2018

March 09, 2018

Class II

Product summary

Firm
St. Jude Medical, Inc.
Event
Event 79560
Status
Terminated
Classification
Class II
Quantity
17 units
Official record key
device-enforcement:Z-1170-2018

Official wording

Reason: 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.

Code information: Lot Number 6210849 Serial Number AVM174.1 Lot Number 6210852 Serial Numbers: AVA560.1, 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 pattern: US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.