Frontier™ IIRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734502948), received between Aug 15, 2018 and Jan 25, 2019 — classified as 2 injuries, 2 malfunctions.

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

5 other recalls cover devices cleared under the same FDA submission (P030035); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A NORMAL PULSE GENERAL CHANGE. DURING THE PRE-GENERATOR CHANGE INTERROGATION OF THE PACEMAKER, THE PHYSICIAN WAS UNABLE TO CHANGE THE DEVICE SETTINGS TO TEMPORARY PACING. FURTHER ATTEMPTS WERE MADE BUT THE PHYSICIAN WAS UNABLE TO CHANGE BOTH THE TEMPORARY OR PERMANENT SETTINGS ON THE DEVICE. THE DEVICE WAS PERFORMING AS PROGRAMMED AND THE PATIENT WAS NOT ADVERSELY AFFECTED. AN EXTERNAL PACING DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8278222 ↗
• MalfunctionDec 20, 2018Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR UNRELATED PROCEDURE. PRIOR TO THE PROCEDURE, THE PULSE GENERATOR COULD NOT BE INTERROGATED. SEVERAL DIFFERENT PROGRAMMERS WERE USED BUT THE ISSUE REMAINED. DURING POST OPERATION CHECK UP, THE DEVICE WAS INTERROGATED WITH NO ISSUES. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8187685 ↗
• InjuryDec 12, 2018Premature Discharge of Battery; Failure to Interrogate; Data Problem; Premature Discharge of Battery; Failure to Interrogate; Data Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR ROUTINE PULSE GENERATOR REPLACEMENT. UPON DEVICE INTERROGATION PRIOR TO THE PROCEDURE, IT WAS DISCOVERED THAT ONLY BASIC PARAMETERS WERE AVAILABLE. NO BATTERY INFORMATION COULD BE OBTAINED. THE PHYSICIAN HAD NOTED THAT ON (B)(6) 2018 THE REMAINING LONGEVITY WAS A YEAR BUT THE DEVICE PREMATURELY REACHED ELECTIVE REPLACEMENT INDICATOR ON (B)(6) 2018. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8157875 ↗
• InjuryAug 15, 2018Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC DURING FOLLOW-UP, DEVICE WAS FOUND TO BE IN BACKUP VVI MODE. IT WAS NOTED THAT THE PATIENT HAD BEEN LOST TO FOLLOW-UP SINCE POST-IMPLANT DEVICE CHECK. DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL ERI. PATIENT¿S CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7787309 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030035. One submission often covers many models, so check the product and lot details in each record.

• Z-1495-2022 · Jun 17, 2022 · Open, Classified
  Merlin PCS 3650 programmer Model 3330 software
• Z-1496-2022 · Jun 17, 2022 · Open, Classified
  Merlin 2 PCS MER37000 programmer Model MER3400 software
• Z-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 Software
• Z-0430-2012 · Sep 23, 2011 · Terminated
  Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
• Z-0429-2012 · Sep 23, 2011 · Terminated
  Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.