A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.
- Company
- Medtronic Neuromodulation
- Recall Initiated
- March 9, 2021
- Recall Number
- Z-1368-2021
- Quantity
- 5332 downloads
- Firm Location
- Minneapolis, MN
Reason for Recall
There are two issues within this correction action: 1. Cycling Issue: When copying settings from a previously used Activa device to a new Percept PC Implantable Neurostimulator (INS) using the "replacement" function of the A610 clinician programmer application, the cycling feature is not copied properly. 2. Log Fill Issue: When the Percept PC INS System Event log is full, the clinician programmer A610 Software application version 2.0.4584, 2.0.4594, 2.0.4605, or 3.0.1057 crashes when it attempts a reading of the last records in the log.
Distribution
Worldwide distribution - US Nationwide distribution in Puerto Rico and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Lithuania, Luxembourg, Malaysia, Malta, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom.
Lot / Code Info
version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.
Root Cause
Under Investigation by firm
Action Taken
Beginning 9-Mar-2021, Medtronic representatives began verbally notifications in order to inform impacted physicians of the issues and provide the mitigations outlined in the letters. Beginning 16-Mar-2021, Medtronic notified its consignees via mail, email, fax, and/or personal visit by Medtronic personnel. The notice described the problems and provided a workaround to use until a software update is available.