InjuryNVN
ELAPASS
Received Apr 9, 2026 · Event occurred Aug 26, 2025
Report 1000165971-2026-00303 · MDR key 24825675
Device
Generic name
Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Ele
Manufacturer
Sorin Group Italia S.r.l. - Crm FacilityModel number
ELAPASS P 758Product problems
- Low impedance
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
AS NO INFORMATION WAS PROVIDED AND AS THE SERIAL NUMBER OF THE LEAD IS UNKNOWN AND THE LEAD IS NOT RETURNED TO BE ANALYSIS, NO CONCLUSION COULD BE ESTABLISHED. THE EVENT IS RECOVERED IN OUR DATABASE FOR TRENDS PURPOSES.
Description of Event or Problem
RV POLARITY SWITCH ON (B)(6) 2025. RV PACE/SENSE POLARITY PROGRAMMED UNIPOLAR. SEE LEAD TRENDS. LOW IMPEDANCE. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).