MalfunctionDTB
RETROX RX 60-BP
Received Mar 23, 2026
Report 1028232-2026-01433 · MDR key 24662328
Device
Generic name
Permanent Pacemaker Electrode
Manufacturer
Biotronik Se & Co. KgModel number
124397Catalog number
124397
Product problems
- Failure to Capture
- Over-Sensing
- High Capture Threshold
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVER SENSING, HIGH THRESHOLDS AND NO CAPTURE. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). MW5183490.
Additional Manufacturer Narrative
THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE MOMENT. THE FILE IS CLOSED. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.