inforMED
InjuryLDF

STREAMLINE TEMPORARY PACING LEADS

Received Jan 14, 2026 · Event occurred Jan 9, 2026

Report 9611350-2026-00001 · MDR key 24068745

Device

Generic name

Electrode, Pacemaker, Temporary

Model number

6500F

Catalog number

6500F

Lot number

700905

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

  • Insufficient Information

Narrative

Description of Event or Problem

ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE PACING WIRE HAD NOT DELIVERED PACING OR PROVIDED CAPTURE, EVEN ON THE MAXIMUM SETTING. IT WAS FURTHER NOTED THAT THE SURGEON HAD USED AN EXTRA SUTURE TIED AROUND THE PACING WIRE IN ORDER TO HELP SECURE THE PACING WIRE TO THE EPICARDIUM. IT WAS REPORTED THAT THE PATIENT REQUIRED MEDICATION DUE TO AN INCREASED HEART RATE WHEN THE PACING WIRE WAS NOT ABLE TO CAPTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Additional Manufacturer Narrative

UPDATED DATA: B.1: ADV EVNT/PROD PROB: B.2: OUTCOME ATTRIBUTED TO ADVERSE EVENT B.5: EVENT DESCRIPTION. 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.

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 24 HOURS OR 1 DAY POST IMPLANT OF THIS TEMPORARY MYOCARDIAL TEMPORARY PACING WIRE, IT WAS REPORTED THAT THE WIRE WAS NOT WORKING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.