STREAMLINE TEMPORARY PACING LEADS
Received Jan 14, 2026 · Event occurred Dec 19, 2025
Report 9611350-2026-00002 · MDR key 24073307
Device
Generic name
Electrode, Pacemaker, Temporary
Manufacturer
Medtronic Fabrication S.a.s.Model number
6495FCatalog number
6495F
Lot number
CBA510207F
Product problems
- Break
- Patient Device Interaction Problem
Patient
NA · Unknown
- Non specific EKG/ECG Changes
Narrative
Description of Event or Problem
MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THIS MYOCARDIAL TEMPORARY PACING LEAD, IT WAS REPORTED THAT THE CONNECTOR PINS CONNECTED TO THE PACING CABLE HAD BROKEN. IT WAS THEN REPORTED THAT THE PATIENT REQUIRED CARDIOPULMONARY RESUSCITATION (CPR). SUBSEQUENTLY, A PERMANENT PACEMAKER WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Additional Manufacturer Narrative
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.