Recall Z-1170-2018 ยท PMP Dorsal Root Ganglion Stimulator For Pain Relief
St. Jude Medical, Inc.
Proclaim DRG Implantable Pulse Generator, Model Number 3664
| Date | Mar 23, 2018 (initiated Mar 9, 2018) |
| Status | Terminated |
| 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. |
| Root cause | Software change control |
| 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. |
| Quantity | 17 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.