Proclaim DRG Implantable Pulse Generator, Model Number 3664
FDA device recall Z-1170-2018 · posted 2018-03-23 · Terminated
Recall details
- Recalling firm
- St. Jude Medical, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- PMP
- Quantity affected
- 17 units
- Distribution
- US
- Date initiated
- 2018-03-09
- Date posted
- 2018-03-23
- Date terminated
- 2020-11-03
- Location
- Plano, TX
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