A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Medtronic Neuromodulation · Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
Open FDA's page for this record- Cfres ID
- 212397
- Product res number
- Z-1506-2025
- Event date initiated
- 2025-01-09
- Event date posted
- 2025-04-01
- Recall status
- Open, Classified
- Res event number
- 96237
- Product code
- LKK
- Product description
- A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
- Code info
- version v.2x, UDI/DI 00763000632793
- Firm FEI number
- 2182207
- Recalling firm
- Medtronic Neuromodulation
- Address 1
- 7000 Central Ave Ne
- City
- Minneapolis
- State
- MN
- Postal code
- 55432-3568
- Additional info contact
- Naomi Rodiles 763-514-2000
- Reason for recall
- Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
- Root cause description
- Under Investigation by firm
- Product quantity
- 4365 units
- Action
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.
- 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.
- PMA numbers
- P860004
- Harmonized identifiers (openFDA)
- Device name
- Pump, Infusion, Implanted, Programmable
- Medical specialty description
- Unknown
- Device class
- 3
- PMA number
- P990034, P860004, P800036, P080012, P140032, P890055
- Registration number
- 3015537318, 1526611, 3018094310, 2124215, 3003120897, 3009183442, 2183319, 1422634, 2032227, 3003174284, 1722746, 3007829657, 3030198397, 2246552, 2182207, 3004593495, 2523676, 3004209178, 2135338
- FEI number
- 3015537318, 1526611, 3018094310, 2124215, 3003120897, 3009183442, 2183319, 1000306216, 3003174284, 3005700659, 3007829657, 3030198397, 1000514656, 2246552, 3003166194, 2182207, 3004369318, 3004593495, 2523676