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5391Recalls & reported problems

Oscor Inc. · Single Chamber External Pacemaker · Class 2

Adverse event reports
2
Deaths reported
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169382978), received between Nov 16, 2017 and Sep 20, 2023 — classified as 1 death, 1 malfunction.

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

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

Device problems

  • Device Slipped1
  • Mechanical Problem1

Patient problems

  • Bradycardia1
  • Cardiac Arrest1
  • Cardiogenic Shock1
  • Death1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionSep 20, 2023Mechanical Problem; Mechanical Problem

    THE EXTERNAL PULSE GENERATOR (EPG) WHICH WAS RETURNED FOR PREVENTIVE MAINTENANCE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MAN UFACTURER¿S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17779728 ↗
  • DeathNov 16, 2017Device Slipped

    IT WAS REPORTED THE PATIENT WENT INTO ASYSTOLE WHEN THE PACING CABLES ON THE EXTERNAL PULSE GENERATOR (EPG) "POPPED OUT" AFTER THEY WERE SECURED INTO THE DEVICE. IT WAS DETERMINED THE PRONGS WERE NOT COMPLETELY TIGHTENED AND THE CABLES SLID OUT. TROUBLESHOOTING SHOWED THE PRONGS CAME LOOSE. FOLLOW UP REVEALED THE TEMPORARY LEAD WAS PLACED IN THE INTENSIVE CARE/CARDIAC CARE UNIT WHEN THE PATIENT WENT INTO SHOCK. THE PATIENT WAS TRANSFERRED TO THE CATHARIZATION LAB FOR PERMANENT PLACEMENT AND WHEN THE PATIENT WAS MOVED THE LEAD "POPPED OUT." THE PATIENT WENT INTO ASYSTOLE AND THERE WAS ELECTRO-MECHANICAL DISSOCIATION. THE LEAD WAS THEN TIGHTENED DOWN, CARDIO-PULMONARY RESUSCITATION WAS STARTED AND THE PATIENT EXPIRED 45 MINUTES TO ONE HOUR LATER. THE STATUS OF THE EPG IS NOT KNOWN AT THIS TIME. ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED FROM THE PHYSICIAN THAT THE PRIMARY CAUSE OF DEATH IS BELIEVED TO BE LACTIC ACIDOSIS AND SECONDARY BRADYCARDIA. FOLLOW-UP REQUESTS FOR FURTHER INFORMATION WERE UNSUCCESSFUL.

    Patient problems: Bradycardia; Cardiac Arrest; Cardiogenic Shock; Death

    MAUDE report 7036844 ↗

Other PULSE-GENERATOR, PACEMAKER, EXTERNAL devices

All PULSE-GENERATOR, PACEMAKER, EXTERNAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.