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FDA (Device enforcement)Recalled 2025-01-09class ii

Medtronic Neuromodulation: A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.

Hazard

Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.

Details from the source

Reason for recall: Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump. Distribution: 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. Quantity: 4365 units Lot/code info: version v.2x, UDI/DI 00763000632793

UPC codes

00763000632793

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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