—#212397

Product

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

FDA product code: LKK — Pump, Infusion, Implanted, Programmable
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P860004
Affected lot / code info: version v.2x, UDI/DI 00763000632793

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medtronic issued an URGENT: MEDICAL DEVICE correction notice to its consignees on 02/28/2025 via email or US mail. The notice explained the issue and provided recommendations to temporarily mitigate the problem, and requested the following: Actions " Share this notice with all those who need to be aware of this issue within your organization and maintain a copy of this notice in your records. " Please provide a copy of the attached patient letter to your affected patients. " Please complete and return the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information. The form may be emailed to neuro.quality@medtronic.com. For questions regarding this communication, please contact Medtronic Technical Services at 1-800-707-0933 or your local Medtronic representative.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568

Distribution

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.

Timeline

Recall initiated: 2025-01-09
Posted by FDA: 2025-04-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212397. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.