NA 5392 (UDI 00643169230859)Recalls & reported problems

Summary

The FDA's MAUDE database contains 930 adverse event reports that list this exact device (DI 00643169230859), received between Dec 9, 2016 and Sep 23, 2026 — classified as 2 deaths, 32 injuries, 896 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (370 reports).

1 other recall cover devices cleared under the same FDA submission (K132924, K150246); 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 25 most recent of 930 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Output Problem

  It was reported that the External Pulse Generator (EPG) pacing cable data was not functioning properly. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870329 ↗
• MalfunctionAug 31, 2026Calibration Problem; Connection Problem

  It was reported that one of the knobs of the External Pulse Generator (EPG) was physically damaged. The EPG has been returned for evaluation and subsequently tested out of specification during manufacturer's analysis. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50517822 ↗
• MalfunctionAug 12, 2026Calibration Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223467 ↗
• MalfunctionJun 26, 2026Battery Problem; Unexpected Shutdown

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG)'S DID NOT STAY ON WHEN CHANGING BATTERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25632608 ↗
• MalfunctionMay 25, 2026Use of Device Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS UNABLE TO WORK PROPERLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25268480 ↗
• MalfunctionMay 18, 2026Output Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) FAILED PREVENTIVE MAINTENANCE TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25198220 ↗
• MalfunctionMay 14, 2026Output above Specifications

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE OF EXTERNAL PULSE GENERATOR (EPG) THE TOLERANCES FOR THE A TRIAL AND VENTRICULAR OUTPUT WERE MEASURING HIGH. IT WAS NOTED THAT THE BATTERY WAS DEPLETED AND REPLACED THE BATTERY WHICH RESOLVED THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25179443 ↗
• MalfunctionMar 30, 2026Output Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) VENTRICULAR OUTPUT WAS SET TO 20 MA, THE RANGE SHOULD BE 18-22 MA BUT IT FLUCTUATED BETWEEN 19MA AND 20MA AND THEN WENT TO 23 MA DURING PREVENTATIVE MAINTENANCE. IT WAS ALSO REPORTED THAT THERE WERE A FEW OTHER MEASUREMENTS WERE ALSO OUT OF RANGE AS WELL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710038 ↗
• MalfunctionMar 12, 2026Mechanical Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) BATTERY DOOR WAS DAMAGED. IT WAS NOTED THAT THE BATTERY DOOR WAS UNABLE TO HOLD THE BATTERY SECURELY, AND THE EPG WAS UNABLE TO FUNCTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577829 ↗
• MalfunctionFeb 24, 2026Connection Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD A BROKEN ATRIAL PIN CONNECTOR PORT, WHICH DID NOT HOLD THE CABLE SECURELY IN PLACE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24424965 ↗
• MalfunctionFeb 2, 2026Unexpected Shutdown

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) SHUT DOWN AFTER BEING POWERED ON AND DURING AN ATTEMPT TO UNLOCK IT. TROUBLESHOOTING STEPS WERE TAKEN TO REPLACE THE BATTERIES TO NO AVAIL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24231987 ↗
• MalfunctionJan 28, 2026No Display/Image

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) TOP SCREEN WAS UNABLE TO DISPLAY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24198356 ↗
• MalfunctionDec 9, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR¿S (EPG) TOP DISPLAY WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23754624 ↗
• MalfunctionNov 30, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR¿S (EPG) ATRIAL OUTPUT KNOB WAS NON-FUNCTIONAL. IT WAS NOTED THAT ALTHOUGH THE KNOB COULD BE TURNED, IT DID NOT CHANGE THE ATRIAL OUTPUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677449 ↗
• MalfunctionNov 21, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR'S (EPG) DISPLAY WAS STARTING TO DISCOLOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23615067 ↗
• MalfunctionNov 6, 2025Connection Problem; Connection Problem

  IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23484167 ↗
• MalfunctionNov 3, 2025Connection Problem; Connection Problem

  THE EXTERNAL PULSE GENERATOR (EPG), WHICH WAS RETURNED AS NO LONGER REQUIRED, SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING THE MA NUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23444743 ↗
• MalfunctionOct 15, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS UNABLE TO CAPTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23298697 ↗
• DeathOct 3, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT MITRAL VALVE AND TRICUSPID VALVE REPAIR SURGERY ON (B)(6) 2025. FOLLOWING THE PROCEDURE, THE PATIENT WAS CONNECTED TO AN EXTERNAL PULSE GENERATOR (EPG) TO PROVIDE PACING SUPPORT. IT WAS NOTED THAT THE EPG¿S SETTINGS WERE REPORTEDLY ESTABLISHED AND MONITORED. ON (B)(6) 2025, THE EPG MISFIRED WHILE IT WAS CONNECTED, RESULTING IN AN R-ON-T PHENOMENON AT A VULNERABLE POINT IN ITS RHYTHM WHICH LED TO A CARDIAC ARREST. IT WAS NOTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, FEAR, AND PHYSICAL DISTRESS FOR MANY HOURS PRIOR TO DEATH. IT WAS REPORTED THAT THE PATIENT SUBSEQUENTLY DIED.

  Patient problems: Angina; Arrhythmia; Asystole; Bradycardia; Cardiac Arrest; Discomfort; Dyspnea; Kidney injury; Muscle Weakness/Atrophy; Pulmonary Edema; Swelling/ Edema; Unspecified Infection

  MAUDE report 23207092 ↗
• MalfunctionAug 13, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD ATRIAL UNDER SENSING ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791541 ↗
• MalfunctionAug 13, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD ATRIAL UNDER SENSING ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791536 ↗
• MalfunctionAug 13, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD ATRIAL UNDER SENSING ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791533 ↗
• MalfunctionAug 13, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD ATRIAL UNDER SENSING ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791527 ↗
• MalfunctionJul 16, 2025No Display/Image; Output Problem; No Display/Image; Output Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) EXPERIENCED INTERMITTENT LOSS OF READING OR CONNECTION DURING USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518775 ↗
• MalfunctionJul 8, 2025Display or Visual Feedback Problem; Mechanical Problem; Display or Visual Feedback Problem; Mechanical Problem

  IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22434549 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132924, K150246. One submission often covers many models, so check the product and lot details in each record.

• Z-1356-2015 · Mar 17, 2015 · Terminated
  Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual ch