Reveal LINQ TM LNQ11Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,592 adverse event reports that list this exact device (DI 00643169732216), received between Feb 9, 2017 and Oct 17, 2025 — classified as 1 death, 43 injuries, 1,548 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (806 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,592 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) HAD MIGRATED IN THE BODY DUE TO BODY WEIGHT LOSS AND HAD STARTED TO CAUSE SIGNIFICANT PAIN. THE ICM HAS BEEN EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 23320892 ↗
• MalfunctionMay 28, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT AN IMPLANTABLE CARDIAC MONITOR (ICM) MIGRATED DOWN THE ABDOMEN. THE ICM REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095844 ↗
• MalfunctionDec 11, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD TELEMETRY ISSUE WITH THE IMPLANTABLE CARDIAC MONITOR (ICM). TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. REFERRED PATIENT TO CLINIC, ADVISED TO TAKE MONITOR WITH THEM. THE REMOTE MONITOR REMAINS IN USE. THE ICM REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300401 ↗
• MalfunctionSep 20, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) HAD MIGRATED TO THE PATIENT'S ABDOMEN (OBSERVED ON XRAY). THE ICM HAD BEEN IMPLANTED SIX YEARS AND EIGHT MONTHS. THE BATTERY WAS NO LONGER FUNCTIONING. THE ICM REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17779459 ↗
• MalfunctionFeb 24, 2023Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED ARTIFACT. THE CURRENT LOCATION OF THE ICM IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16434390 ↗
• MalfunctionJan 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) WAS NOT FUNCTIONING WITHIN NORMAL TOLERANCES. THE ICM WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16224387 ↗
• MalfunctionDec 2, 2022Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD NO TELEMETRY WITH THE IMPLANTABLE CARDIAC MONITOR (ICM). TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE PATIENT WAS REFERRED TO THE CLINIC. THE REMOTE MONITOR REMAINS IN USE. THE ICM REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15904445 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) PATIENT EXPERIENCED AN INFECTION. THE ICM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15379703 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) PATIENT EXPERIENCED AN INFECTION. THE ICM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 14367378 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) PATIENT EXPERIENCED AN INFECTION. THE ICM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 14084401 ↗
• MalfunctionMar 9, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE IMPLANTABLE CARDIAC MONITOR (ICM) PATIENT THAT THE DEVICE HAD MIGRATED IN THEIR CHEST. THE ICM WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13711544 ↗
• MalfunctionSep 29, 2021Failure to Interrogate; Communication or Transmission Problem; Failure to Interrogate; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) HAD NO TELEMETRY AND COULD NOT BE INTERROGATED WITH THE MOBILE APPLICATION. THE ICM REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546585 ↗
• MalfunctionAug 27, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) HAD NO TELEMETRY. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12376320 ↗
• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) PATIENT EXPERIENCED AN INFECTION. THE ICM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12299329 ↗
• MalfunctionAug 4, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD NO TELEMETRY WITH THE IMPLANTABLE CARDIAC MONITOR (ICM). THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12273021 ↗
• InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR A PARTIAL ELECTRICAL RESET TO IMPACT THE DEVICE¿S ABILITY TO DETECT BRADYCARDIA AND PAUSE EPISODES, THE IMPLANTABLE CARDIAC MONITOR (ICM) WAS PROPHYLACTICALLY REPLACED/EXPLANTED. NO DEVICE MALFUNCTION WAS OBSERVED WHILE THE DEVICE WAS IN USE, HOWEVER, GIVEN THE POTENTIAL FOR LOSS OF DEVICE FUNCTIONALITY, THE ICM WAS EXPLANTED AND REPLACED TO PRECLUDE HARM TO THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12272777 ↗
• MalfunctionJul 14, 2021Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED AN ELECTRICAL RESET. IT WAS NOTED THAT THE DEVICE HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) AND WAS IMPLANTED FOR GREATER THAN ITS EXPECTED LONGEVITY. THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12165227 ↗
• MalfunctionJul 14, 2021Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DETECTED FALSE ATRIAL FIBRILLATION (AF) EPISODES DUE TO THE SENSITIVITY OF THE DEVICE. THE ICM REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12165175 ↗
• MalfunctionJun 15, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO ESTABLISH TELEMETRY WITH THE IMPLANTABLE CARDIAC MONITOR (ICM). THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11999206 ↗
• MalfunctionJun 4, 2021Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED ERRONEOUS DATA/COUNTERS DUE TO END OF SERVICE (EOS). THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11937701 ↗
• MalfunctionJun 2, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) WAS UNABLE TO CONNECT WITH THE REMOTE MONITOR READER AND THEY HAD THE SAME ISSUE WITH A PREVIOUS MONITOR. THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918625 ↗
• MalfunctionMay 19, 2021Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED POSSIBLE UNDERSENSING AND OVERSENSING. THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11847389 ↗
• MalfunctionMay 18, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS CONFIRMED THAT THE ICM HAD REACHED END OF SERVICE (EOS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11839803 ↗
• MalfunctionMay 5, 2021Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) WAS UNABLE TO BE INTERROGATED DUE TO THE DEVICE BATTERY WHICH IS NO LONGER FUNCTIONAL. IT WAS NOTED THAT THE DEVICE WAS IMPLANTED FOR GREATER THAN ITS EXPECTED LONGEVITY. THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11775357 ↗
• MalfunctionApr 28, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) HAD NO TELEMETRY WITH THE REMOTE MONITOR. THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11736699 ↗