Reveal LINQ, RevealRecalls & reported problems across all models

We found 2 models of Reveal LINQ, Reveal by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 700 adverse event reports in the FDA's MAUDE database, received between Dec 10, 2014 and Sep 16, 2024 — classified as 1 death, 10 injuries, 689 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (287 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Reveal LINQ, Reveal problems

Reveal LINQ, Reveal models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Reveal LINQ™, Reveal® LNQ11

  DETECTOR AND ALARM, ARRHYTHMIA
  1 death393 reports
• Reveal LINQ™, Reveal® LNQ11

  DETECTOR AND ALARM, ARRHYTHMIA
  307 reports

Recent Reveal LINQ, Reveal adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DID NOT RECORD THE CHANGES FOR EPISODES. 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 20223595 ↗
• MalfunctionJul 30, 2021Reset Problem; Reset Problem

  IT WAS FURTHER REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) MAY HAVE REACHED END OF SERVICE (EOS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12251697 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE IMPLANTABLE CARDIAC MONITOR (ICM) PATIENT THAT THE DEVICE WAS REMOVED DUE TO INFECTION. THE ICM IS NO LONGER IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12098702 ↗
• MalfunctionApr 7, 2021Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DETECTED A TACHYCARDIA EPISODE DUE TO ELECTROMAGNETIC INTERFERENCE (EMI). THE DEVICE 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 11626211 ↗
• InjuryJun 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) CAUSED THE PATIENT TO EXPERIENCE PAIN. THE ICM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 10141871 ↗
• MalfunctionMay 7, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DID NOT HAVE TELEMETRY. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10031963 ↗
• MalfunctionMar 30, 2020Battery Problem; Communication or Transmission Problem; Battery Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED NO TELEMETRY AT RECOMMENDED REPLACEMENT TIME (RRT). THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9896554 ↗
• MalfunctionJan 29, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) BATTERY IS DEAD ALREADY AND NO LONGER WORKING. THE ICM REMAINS IN PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9641096 ↗
• MalfunctionJan 16, 2020Communication or Transmission Problem; Communication or Transmission Problem

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9595276 ↗
• MalfunctionDec 3, 2019Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) WAS BROKEN INTO 3 PIECES IN THE BODY WITH ONE OF THE PIECES BEING IN THE PELVIS. THE DEVICE REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9400337 ↗
• MalfunctionSep 26, 2019Communication or Transmission Problem; Communication or Transmission Problem

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9122014 ↗
• InjurySep 9, 2019Adverse 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 8973785 ↗
• MalfunctionAug 12, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DEVICE REACHED END OF SERVICE (EOS) EARLIER THAN EXPECTED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8882321 ↗
• MalfunctionJul 19, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DEVICE REACHED RECOMMENDED REPLACEMENT TIME (RRT) EARLIER THAN EXPECTED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8806517 ↗
• MalfunctionJul 10, 2019Failure to Interrogate; Battery Problem; Failure to Interrogate; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) COULD NOT BE READ BY THE PROGRAMMER. IT WAS FURTHER REPORTED THAT THE ICM BATTERY IS DEAD. THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8774783 ↗

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