Device product
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Z-1506-2025
Product summary
- Event
- Event 96237
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4365 units
- Official record key
device-enforcement:Z-1506-2025
Official wording
Reason: Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
Code information: version v.2x, UDI/DI 00763000632793
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Puerto Rico, Spain, Sweden, Switzerland, United Kingdom.
Derived failure modes
-
Unknown
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.