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Terminated

Proclaim DRG Implantable Pulse Generator, Model Number 3664

FDA Recall Z-1170-2018 · Posted 2018-03-23

Recalling FirmSt. Jude Medical, Inc.
Recall StatusTerminated
Product CodePMP
Date Initiated2018-03-09
Date Terminated2020-11-03
Product Quantity17 units

Reason for Recall

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.

Firm Action

Notification material in the form of a Customer Letter was hand-delivered to two consignees in the US beginning 09 Mar 2018. The Physician Letter was hand-delivered to impacted implanting physicians, beginning 14 Mar 2018. A Patient Letter was delivered via certified mailing to all active implanted patients in the US, beginning 14 Mar 2018.

Root Cause

Software change control

Distribution Pattern

US

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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