BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER
Received Feb 27, 2026 · Event occurred Feb 19, 2026
Report 1018233-2026-01377 · MDR key 24475402
Device
Generic name
Temporary Pacing Electrode Catheter
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
006173P
Lot number
GFKV1726
Product problems
- Failure to Capture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
Description of Event or Problem
IT WAS REPORTED THAT AFTER USE OF THE BALLOON TEMPERATURE PACING ELECTRODE THE PATIENT ONCE AGAIN HAD A SUFFICIENT INTRINSIC RHYTHM POST INTERVENTIONAL DEFECT. THE PACEMAKER WAS REPLACED IN THE RECOVERY ROOM. THERE WERE NO COMPLICATIONS. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 26FEB2026, STATED THAT NO PATIENT HARM OCCURRED.