Electromagnetic Interference
Conditions
Brief summary
Subjects with Medtronic Micra leadless pacemaker who require surgical procedures will have postoperative interrogations reviewed for evidence of electromagnetic interference (EMI).
Detailed description
Patients with pacemakers have a potential risk of EMI from sources including electrosurgery which can cause oversensing, pacing inhibition and device reset. There is limited data on surgical EMI in Medtronic Micra leadless pacemakers. The goal of this study is to evaluate for surgical EMI in subjects with leadless pacemakers. Subjects with Micra leadless pacemakers requiring surgery will have procedure records reviewed for type of procedure and use of electrosurgery. Next postoperative device interrogation will be reviewed for evidence of EMI. EMI will be evaluated by review of sensing integrity counter, heart rate histograms and device reset.
Interventions
OTHERsurgical procedure
Surgical procedure
Sponsors
Edward-Elmhurst Health System
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* subjects with an implanted Micra pacemaker who required a surgical procedure
Exclusion criteria
* no Micra pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EMI | up to 6 months next postop interrogation | Number of subjects with evidence of EMI determined by sensing integrity counter and heart rate histograms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device reset | up to 6 months next postop interrogation | Number of subjects with change in programmed parameters showing device reset VVI 65 5V@.4ms |
Countries
United States
Outcome results
None listed