PharmacovigilanceOfficial

Medtronic releases updated myPTM app for SynchroMed pumps to fix slowdown on patient therapy manager

🇳🇱 IGJ · Sun 08 Nov 2026

Version 2.0.3155 or later of the SynchroMed A820 myPTM app addresses delays reported by patients using the PTM with SynchroMed II and III infusion pumps.

Medtronic has made a new version of the SynchroMed A820 myPTM app available for installation on the patient therapy manager (PTM). The Dutch healthcare inspectorate, IGJ, published the manufacturer's notice, which is dated 29 October 2026 and was posted on the IGJ site on 9 November 2026.

The update, version v2.0.3155 or later, resolves a software problem that Medtronic communicated earlier. The issue affects earlier software versions used with the model 8637 SynchroMed II and model 8667 SynchroMed III infusion pumps.

According to the notice, Medtronic received patient reports of delays when using the PTM to interact with a SynchroMed pump. The delays can occur during actions such as interrogation (reading out the pump), resynchronisation, bolus requests and disconnecting the PTM. The company says the total amount of data stored in the PTM after each of these actions slows the myPTM app.

The notice is a field safety notice (FSN) from the manufacturer. Under the EU framework, manufacturers must monitor their devices after they reach the market and, where a risk to users arises, take action and inform users and the competent authorities through such a notice. Medtronic B.V. is listed as the authorised representative. The source text does not describe any patient injuries or specify the required user actions beyond the availability of the new version.

What it means for your team

  • Teams supporting SynchroMed II (model 8637) and SynchroMed III (model 8667) users should confirm that PTMs are running myPTM v2.0.3155 or later.
  • The update closes out a previously communicated software issue, so firms should link it to the earlier FSN in their records and any related field-action tracking.
  • The source describes slowdowns during interrogation, resynchronisation, bolus requests and PTM disconnection; complaint and vigilance teams may wish to watch for reports of these events.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

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