TB 020024Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00836559009924), received between Sep 4, 2018 and Sep 4, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

1 other recall cover devices cleared under the same FDA submission (K861403); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2018Fracture; Fracture

  THE CUSTOMER REPORTED THE PATIENT REPORTED FEELING WEAK; WE ESTABLISHED LACK OF STIMULATION FROM THE LEADS. PER THE EKG LINE ON AVBIII MONITOR, WITH REPLACEMENT RHYTHM IN NARROW QRS, FREQUENCY 40/MIN, PATIENT ABLE TO SUSTAIN CIRCULATION. DISTURBANCE IN CIRCULATION OCCURRED DIRECTLY AFTER ASSUMING SITTING POSITION. MULTIPLE TIMES, INCLUDING DURING ECHO CONTROL, THE ELECTRODE WAS REPOSITIONED WITHOUT ACHIEVING EFFECTIVE STIMULATION. LEAD FIXATION CHECKED AT GENERATOR AND BATTERY CHANGED WITH NO EFFECT. ASSISTANCE FROM CARDIOLOGY CLINIC ON-CALL DOCTOR; WE DISCOVERED A DEFECT IN THE LEADS PROVIDING IMPULSE FOR THE ELECTRODE. WE REMOVED THE DAMAGED FRAGMENT, RECONNECTED TO THE GENERATOR, OBTAINING EFFECTIVE STIMULATION CIRCA 80/MIN. PATIENT CONSCIOUS, ABLE TO SUSTAIN BREATHING AND CIRCULATION, NO CONSCIOUSNESS DISTURBANCES. INCREASING ISUPREL DOSAGE MANAGED TO ACHIEVED PATIENT'S OWN FREQUENCY AT AROUND 90/MIN. WE PERFORMED PRECAUTIONARY CHEST RTG. IN THE EVENING, FREQUENCY DOWN AGAIN TO 40/MIN, THE PATIENT REPORTED WEAKNESS. WE DISCOVERED A FRACTURE OF THE IMPULSE-TRANSFERRING LEAD. CARDIOLOGY CLINIC DOCTOR - REMOVED THE FAULTY FRAGMENT, ACHIEVING STIMULATION. ON (B)(6) 2014 WE CHANGED

  Patient problems: Heart Failure

  MAUDE report 7842766 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K861403. One submission often covers many models, so check the product and lot details in each record.

• Z-0391-2019 · Sep 26, 2018 · Terminated
  TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray