NA 5392 (UDI 00643169508767)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,934 adverse event reports that list this exact device (DI 00643169508767), received between Dec 9, 2016 and Sep 11, 2026 — classified as 1 death, 59 injuries, 1,874 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (852 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 1,934 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Device Sensing Problem

  It was reported that the External Pulse Generator (EPG) was unable to read properly. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50730141 ↗
• MalfunctionAug 28, 2026No Display/Image

  It was reported that the External Pulse Generator (EPG)'s screen was damaged and it was noted there was deep gash on the screen. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50501369 ↗
• MalfunctionJul 1, 2026No Display/Image; Connection Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG)'S SCREEN AND ATRIAL CONNECTOR PORT HAD AN ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25686075 ↗
• MalfunctionJul 1, 2026No Display/Image

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG)'S SCREEN HAD AN ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25686047 ↗
• MalfunctionJun 8, 2026Mechanical Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) REQUIRED A BATTERY DRAWER REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25423360 ↗
• MalfunctionJun 5, 2026Mechanical Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) BATTERY COMPARTMENT SPRING WAS BROKEN. NO PATIENT COMPLICATIONS HAVE BEEN RE PORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25404261 ↗
• 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 25268471 ↗
• MalfunctionApr 29, 2026No Display/Image

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG)'S DISPLAY BLEED ON TOP RIGHT CORNER OF SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024523 ↗
• MalfunctionApr 27, 2026No Display/Image

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD DAMAGE ON THE INSIDE OF THE DISPLAY SCREEN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24995389 ↗
• MalfunctionApr 23, 2026No Display/Image

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) EXHIBITED A DISPLAY ANOMALY AT THE TOP RIGHT CORNER. THERE WAS NO PATIENT IN VOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965428 ↗
• MalfunctionApr 21, 2026Output Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR'S (EPG) PACING CURRENT WAS NOT WITHIN TOLERANCE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24935876 ↗
• MalfunctionApr 21, 2026Output Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR'S (EPG) PACING CURRENT WAS NOT WITHIN TOLERANCE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24935875 ↗
• MalfunctionApr 20, 2026Calibration Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG)'S KNOB WERE BROKEN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24922645 ↗
• MalfunctionApr 1, 2026Connection Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG)'S VENTRICULAR PORT WAS BROKEN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24751516 ↗
• InjuryApr 1, 2026No Device Output

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS NOT PACING WHEN CONNECTED TO THE PATIENT, AS INDICATED ON THE MONITOR, WHILE THE EPG REMAINED POWERED ON. TROUBLESHOOTING STEPS WERE TAKEN TO REPLACE THE EPG, WHICH RESOLVED THE ISSUE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750725 ↗
• MalfunctionMar 12, 2026Unexpected Shutdown

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS RANDOMLY TURNING OFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577632 ↗
• MalfunctionMar 6, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) DISPLAYED AN ERROR CODE DURING PREVENTATIVE MAINTENANCE TESTING. TROUBLESHOOTING STEPS WERE TAKEN INCLUDING POWERED DOWN THE UNIT TO NO AVAIL. 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 24528418 ↗
• MalfunctionFeb 4, 2026No Display/Image

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR'S (EPG) TOP DISPLAY WAS NOT FUNCTIONAL WHEN POWERED ON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256238 ↗
• MalfunctionJan 29, 2026Output Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) MEASURED OUTSIDE THE EXPECTED TOLERANCE FOR THE REFRACTORY PERIOD DURING THE PREVENTIVE MAINTENANCE CHECK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208809 ↗
• MalfunctionJan 26, 2026Connection Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD BROKEN PLASTIC SURROUNDING OF ATRIAL AND VENTRICULAR CONNECTOR PORTS. IT WAS NOTED THAT THE LEADS WERE NOT STABLE IN THE CONNECTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177252 ↗
• MalfunctionDec 23, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE KNOB ON THE EXTERNAL PULSE GENERATOR (EPG) WAS DETACHED, AND AFTER REATTACHMENT, THE KNOB REMAINED LOOSE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878790 ↗
• MalfunctionDec 19, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR¿S (EPG) ATRIAL AND VENTRICULAR CONNECTORS WERE BROKEN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847442 ↗
• MalfunctionNov 27, 2025No Display/Image; No Display/Image

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669200 ↗
• MalfunctionNov 27, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR'S (EPG) VENTRICULAR CONNECTOR PORT WAS CRACKED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663972 ↗
• MalfunctionNov 25, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) FAILED TO REMAIN ON FOR THIRTY SECONDS WITHOUT THE BATTERY, DURING PREVENTATIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23653439 ↗

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