REVEAL XTRecalls & reported problems across all models

We found 2 models of REVEAL XT by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 54 adverse event reports in the FDA's MAUDE database, received between Jun 8, 2017 and Apr 24, 2023 — classified as 1 injury, 53 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (29 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 XT problems

REVEAL XT models

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

• REVEAL® XT 9529

  DETECTOR AND ALARM, ARRHYTHMIA
  51 reports
• REVEAL® XT 9529

  DETECTOR AND ALARM, ARRHYTHMIA
  3 reports

Recent REVEAL XT adverse event reports

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

• MalfunctionApr 24, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS NOT COLLECTING INFORMATION FROM THE IMPLANTABLE CARDIAC MONITOR (ICM) DEVICE. THE ICM HAD NO TELEMETRY. TROUBLESHOOTING STEPS WERE TAKEN AND STILL NOT GETTING THE PROGRESS BAR. THE CALLER WAS REFERRED TO CLINIC. THE REMOTE MONITOR REMAINS IN USE AND 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 16794804 ↗
• MalfunctionApr 7, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO ESTABLISH TELEMETRY WITH THE IMPLANTABLE CARDIAC MONITOR (ICM). IT WAS ALSO RE PORTED THAT AN ERROR CODE OF 7332 APPEARED INDICATING THE CONNECTION TO LOOK UP THE AFFILIATED DEVICE IN THE REMOTE MONITORING NETWORK WAS UNSUCCESSFUL OR TIMED OUT. TROUBLESHOOTING STEPS WERE EXHAUSTED AND STILL PROGRESS BAR WOULD NOT START. THE PATIENT WAS REFER RED TO THE CLINIC AND TO TAKE THE MONITOR TO THE APPOINTMENT. THE 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 16700184 ↗
• MalfunctionNov 23, 2022Communication 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). TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. 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 15850537 ↗
• MalfunctionAug 31, 2021Signal Artifact/Noise; Over-Sensing; Under-Sensing; Signal Artifact/Noise; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED UNDERSENSING ON ASYSTOLE AND BRADYCARDIA EPISODES. IT WAS FURTHER REPORTED THAT THE DEVICE EXPERIENCED OVERSENSING NOISE ON EPISODES. 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 12390597 ↗
• MalfunctionMay 27, 2021Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DETECTED FALSE PAUSE EPISODES DUE TO UNDERSENSING. IT WAS FURTHER REPORTED THAT THE ICM DETECTED FALSE VENTRICULAR TACHYCARDIA (VT) DUE TO 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 11892837 ↗
• MalfunctionMay 26, 2021Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE IMPLANTABLE CARDIAC MONITOR (ICM) DID NOT ACQUIRE A SIGNAL, THE SIGNAL APPEARED LIKE NOISE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11884121 ↗
• MalfunctionMay 21, 2021Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT ON THE DAY OF THE IMPLANT PROCEDURE, THE IMPLANTABLE CARDIAC MONITOR (ICM) BASELINE WAS GOING FROM "RAIL TO RAIL", AND IT WAS SUSPECTED THE ICM WAS NOT SENSING PROPERLY. 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 11863647 ↗
• MalfunctionMay 7, 2021Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED UNDERSENSING R-WAVES/PREMATURE VENTRICULAR CONTRACTIONS (PVC) WHICH RESULTED IN FALSE PAUSE AND BRADYCARDIA EPISODES. 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 11788908 ↗
• InjuryMar 4, 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 AND THE SITE WOULD NOT HEAL PROPERLY. THE DEVICE WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 11409337 ↗
• MalfunctionMar 1, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) HAD NO TELEMETRY. 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 11391641 ↗
• MalfunctionJan 22, 2021Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXHIBITED VENTRICULAR OVERSENSING AND VENTRICULAR UNDERSENSING. 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 11213939 ↗
• MalfunctionNov 25, 2020Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED UNDERSENSING. 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 10904411 ↗
• MalfunctionJun 23, 2020Communication or Transmission Problem; Communication or Transmission Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10183008 ↗
• MalfunctionJun 15, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DETECTED FASCICULAR VENTRICULAR TACHYCARDIA (FVT) DUE TO OVERSENSING. THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10152403 ↗
• MalfunctionMay 20, 2020Over-Sensing; Over-Sensing

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10073867 ↗

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