MalfunctionLWP
ACCOLADE MRI DR
Received Jul 31, 2026 · Event occurred Jul 15, 2026
Report 2124215-2026-41152 · MDR key 50094412
Device
Generic name
Pacemaker
Manufacturer
Boston Scientific CorporationModel number
L311Catalog number
L311
Lot number
948974
Product problems
- High impedance
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that this pacemaker system triggered lead safety switch (LSS) due to a high out of range pacing impedance measurement of 2034 Ohms. This device remains in service. No adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress. This report will be updated when product investigation is complete.