STREAMLINE TEMPORARY PACING LEADS
Received Mar 3, 2026 · Event occurred Jan 27, 2026
Report 9611350-2026-00005 · MDR key 24495895
Device
Generic name
Electrode, Pacemaker, Temporary
Manufacturer
Medtronic Fabrication S.a.s.Model number
6500FCatalog number
6500F
Lot number
DAB751306F
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THIS TEMPORARY PACING LEAD "HAS A COIL OF VERY STIFF SUTURE MATERIAL THAT IS LACERATING THE MYOCARDIUM". 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.