Signal · Regulation & Trade
CareLink™ SmartSync™ Device Manager
What the source reported
Source-reportedA complaint from the CareLink network reported a sudden decrease in the Remaining Longevity of a patient's Micra VR CIED from 3 years to 6 months following a remote transmission, which was later found to be incorrect. Analysis revealed a calculation issue in SmartSync and CareLink for Micra VR2 and Micra AV2 devices, occurring under specific conditions. This miscalculation stems from a software error where a function received an integer instead of a real data type, defaulting the average pacing rate to 60 BPM and resulting in inaccurate Remaining Longevity estimates.
- Publication
- Health Canada - Medical Device Alerts and Recalls (RSS) · Government/Regulator
- Published
- 1st October 2026
- Original report
- recalls-rappels.canada.ca
ProcIntel stores what the source published in its feed — a headline, a summary and a link. It does not store or reproduce the full article.
What ProcIntel recorded
ProcIntel-derived- Category
- Regulation & Trade
- Geography
- Canada
- Organisations
- None identified
- Collected
- 1st October 2026 · 19:59
Initial assessment ProcIntel's automatic, provisional read of this individual Signal -- Initial Significance and Initial Confidence, computed deterministically before any Event extraction or human review.
A provisional, automatically computed reading of this individual Signal, before Event extraction or human review. Not a final rating.
Initial Significance Moderate (26.0/100). Strongest contributor: Procurement Impact (21.0/30 points). Limiting factor: Geographic Breadth (0.0/10 points). Initial Confidence Low (39/100, data sufficiency: Insufficient). Strongest contributor: Source Authority (40.0/40 points). Limiting factor: Specificity (0.0/20 points). Capped at 39 (Low) -- insufficient structured evidence to support a higher Confidence reading, regardless of source authority.
- Strongest contributor
- Procurement Impact
- Limiting factor
- Geographic Breadth