ELAPASS
Received Jan 30, 2026 · Event occurred Jan 7, 2026
Report 1000165971-2026-00040 · MDR key 24219586
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 752Product problems
- Intermittent Capture
- High impedance
Patient
NA · Unknown
- Syncope/Fainting
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
IT WAS REPORTED THAT DURING A CLINIC VISIT, THE PATIENT WITH THE PACEMAKER SYSTEM REPORTED A SYNCOPAL EPISODE. DEVICE WAS INTERROGATED AND FOUND TO HAVE A LEAD SAFETY SWITCH (LSS) FROM BIPOLAR TO UNIPOLAR CONFIGURATIONS DUE LOW OUT OF RANGE PACING IMPEDANCES ON THIS RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) WAS CONSULTED FOR FURTHER REVIEW DUE TO SUSPICION OF LOSS OF CAPTURE (LOC) OF THE RV LEAD IN BIPOLAR CONFIGURATIONS. IT IS NOTED THAT THE LEAD IS A NON-(B)(6) LEAD. TS REVIEWED THE DATA AND DISCUSSED POSSIBLE CAUSES RECOMMENDING X-RAY IMAGES AND POSSIBLE LEAD REVISION PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS NON-(B)(6) RV LEAD REMAINS IN SERVICE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B) (2).