STREAMLINE TEMPORARY PACING LEADS
Received Apr 16, 2026 · Event occurred Mar 16, 2026
Report 2025587-2026-00422 · MDR key 24896642
Device
Generic name
Electrode, Pacemaker, Temporary
Manufacturer
Medtronic Fabrication S.a.s.Model number
6494FCatalog number
6494F
Lot number
UNKNOWN
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- Insufficient Information
Narrative
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.
Description of Event or Problem
MEDTRONIC RECEIVED INFORMATION THAT 9 DAYS POST IMPLANT OF THIS UNIPOLAR TEMPORARY PACING LEAD, IT WAS REPORTED THAT PACING WAS NOT BEING DELIVERED. THE TEMPORARY PACING LEAD WAS THEN EXPLANTED. IT WAS FURTHER REPORTED UPON EXPLANT, IT WAS DISCOVERED THAT THE TEMPORARY PACING LEAD TIPS HAD BROKEN OFF AND REMAINED IN THE PATIENT. SUBSEQUENTLY, THE PATIENT THEN HAD A PERMANENT PACEMAKER IMPLANTED. DURING THE PERMANENT PACEMAKER IMPLANT, THE TEMPORARY PACING LEAD TIPS WERE REMOVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem
ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE PERMANENT PACEMAKER WAS IMPLANTED 1 DAY POST TEMPORARY PACING LEAD EXPLANT. IT WAS FURTHER NOTED THAT THE CONNECTOR PIN WAS PROTECTED WHEN NOT IN USE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Additional Manufacturer Narrative
UPDATED DATA: B.5: EVENT DESCRIPTION D.3: MFR NAME:, STREET 1:, MFR CITY:, COUNTRY CODE:, POSTAL CODE: H.6: CODING. 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.