STREAMLINE™ 6492FRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169310087), received between Jun 22, 2023 and Jun 22, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Sense” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2023Failure to Sense; Adverse Event Without Identified Device or Use Problem; Failure to Sense; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE USE OF A TEMPORARY PACING LEAD, THE PACING LEAD FAILED TO SENSE. IT WAS REPORTED THAT THERE WERE ISSUES WITH THE A WIRES AND A THRESHOLD CHECK WAS PERFORMED ONCE THE PATIENT STABILIZED. THE PACER SETTINGS WERE DDI MODE, ATRIAL AND VENTRICULAR MILLIAMPS SET AT 10, AND SENSITIVITY WAS SET TO 0.4 MILLIVOLTS (MV) FOR ATRIA AND 0.8 MV FOR VENTRICLE. IT WAS REPORTED THAT THE PATIENT INITIALLY HAD A HEART RATE OF 60 BEATS PER MINUTE (BPM) AND "THE PACER" WAS SLOWLY "TURNED  UP" TO PACE ABOVE INTRINSIC RHYTHM WHEN THE ISSUE OCCURRED. IT WAS NOTED THAT THE PATIENT¿S INTRINSIC RHYTHM WAS A NORMAL SINUS RHYTHM IN THE 70S BPM. IT WAS REPORTED THAT THIS RESULTED IN AN "R ON T EVENT" OCCURRING AND THE PATIENT DEVELOPED VENTRICULAR TACHYCARDIA AND HAD TO BE CODED. THE PATIENT SUBSEQUENTLY REGAINED CONSCIOUSNESS. IT WAS ALSO NOTED THAT THE PATIENT HAD DEVELOPED VENTRICULAR FIBRILLATION (VF) DURING THIS TIME. IT WAS MENTIONED THAT STAFF ARE FAMILIAR IN THE USE OF THIS MODEL OF PACING LEAD. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Tachycardia; Ventricular Fibrillation

  MAUDE report 17181048 ↗
• InjuryJun 22, 2023Failure to Sense; Adverse Event Without Identified Device or Use Problem; Failure to Sense; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A TEMPORARY PACING LEAD, THE PACING LEAD FAILED TO SENSE. IT WAS STATED THAT THE PATIENT HAD VENTRICULAR HEART WIRES AND THE EXTERNAL PACEMAKER WAS SET TO VVI PACING, AND THE VENTRICULAR SENSITIVITY WAS DECREASED FROM 2 MILLIVOLTS (MV), WHICH WAS THE DEFAULT SETTING, TO 0.8 MV PER THE SITES PROTOCOL. IT WAS REPORTED THAT THIS RESULTED IN AN "R ON T EVENT" OCCURRING AND THE PATIENT DEVELOPED VENTRICULAR TACHYCARDIA AND HAD TO BE CODED. THE PATIENT SUBSEQUENTLY REGAINED CONSCIOUSNESS. IT WAS ALSO NOTED THAT THE PATIENT HAD DEVELOPED VENTRICULAR FIBRILLATION (VF) DURING THIS TIME. IT WAS MENTIONED THAT STAFF ARE FAMILIAR IN THE USE OF THIS MODEL OF PACING LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tachycardia; Ventricular Fibrillation

  MAUDE report 17181002 ↗