FDA Recall
Terminated
Proclaim DRG Implantable Pulse Generator, Model Number 3664
Recall: Z-1170-2018
·
Initiated March 9, 2018
Recall
- Recall Number
- Z-1170-2018
- Event Number
- 79560
- Firm
- St. Jude Medical, Inc.
- FEI Number
- 1627487
- Product Code
- PMP
- Status
- Terminated
- Root Cause
- Software change control
- Initiated
- March 9, 2018
- Posted
- March 23, 2018
- Terminated
- November 3, 2020
- Address
- 6901 Preston Rd, Plano, TX, 75024-2508
Description
Proclaim DRG Implantable Pulse Generator, Model Number 3664
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.
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.
Distribution
US
Quantity
17 units