Reveal LINQ™ LNQ11 (UDI 00643169845749)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7,581 adverse event reports that list this exact device (DI 00643169845749), received between Jun 8, 2017 and Jun 3, 2026 — classified as 457 injuries, 7,124 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (3,300 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 1, 2021Class IIOpen, Classified

   Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pause events to clinicians.

   Z-2102-2021 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 7,581 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING AN ATTEMPT TO SEND A TRANSMISSION USING THE MYCARELINK EXTERNAL MONITOR/READER WITH AN IMPLANTABLE CARDIAC MONITOR, THERE WAS NO TELEMETRY AND THE MONITOR WAS NOT READING THE IMPLANTED DEVICE. IT WAS ALSO REPORTED THAT THE INITIAL TRANSMISSION WAS NOT SENT, THE PROGRESS BAR DID NOT APPEAR DURING THE ATTEMPTED TRANSMISSION, AND THERE WAS A CONNECTIVITY ISSUE BETWEEN THE EXTERNAL MONITOR/READER AND THE IMPLANTED DEVICE, WITH THE PATIENT NOT CONNECTED TO THE DEVICE. IT WAS CONFIRMED THAT THE DOCTOR'S OFFICE HAD INCORRECT INFORMATION REGARDING THE CUSTOMER'S DEVICE, WHICH WAS PREVENTING THE MONITOR FROM SENDING TRANSMISSIONS. THE PATIENT WAS REFERRED TO THE CLINIC. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25371356 ↗
• MalfunctionMay 20, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING USE OF THE MYCARELINK READER WITH AN IMPLANTABLE CARDIAC MONITOR (ICM), THERE WAS NO TELEMETRY DUE TO A READER POSITION ISSUE. THE PATIENT WAS INSTRUCTED TO PLACE A DRY WASHCLOTH BETWEEN THE READER AND THE ICM AND TO REMOVE ANY INTERFERENCE WITHIN 6 FEET, AND TO CHECK WHETHER THE PROGRESS BAR FILLED. THE PATIENT WAS REFERRED TO THE CLINIC FOR FOLLOW-UP DUE TO THE UNRESOLVED TELEMETRY/CONNECTIVITY ISSUE. 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 25234527 ↗
• MalfunctionFeb 26, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD UNSUCCESSFUL DAILY WIRELESS AUDIT (DWA). IT WAS ALSO REPORTED THAT THE REMOTE MONITOR HAD NO TELEMETRY WITH THE IMPLANTABLE CARDIAC MONITOR (ICM). IT WAS VERIFIED THAT THE REMOTE MONITOR REMAINED SET UP. TROUBLESHOOTING STEPS WERE PERFORMED, INCLUDING ADDRESSING THE READER POSITION ISSUE WITH THE PROGRESS BAR NOT FILLING. THE PATIENT WAS REFERRED TOTHE CLINIC FOR FURTHER ASSISTANCE. 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 24453573 ↗
• InjuryJan 15, 2026Appropriate Device Problem Term/Code Not Available

  THE IMPLANTABLE CARDIAC MONITOR (ICM) PATIENT REPORTED THAT THEY HAD AN ALLERGIC REACTION TO THE DEVICE. THE ICM HAD BEEN IMPLANTED OVER 67 MONTHS AT THE TIME OF THE EVENT. THE ICM WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24078183 ↗
• InjuryJan 9, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) WAS DEEPLY EMBEDDED IN DEEP TISSUE AND WAS CAUSING THE PATIENT PAIN. IT WAS ALSO NOTED THAT THE ICM HAD REACHED END OF SERVICE (EOS). AS IT WAS NOT POSSIBLE TO LOCATE THE ICM BY PALPATION, FLUOROSCOPY AND A PROPER SURGICAL TRAY WAS USED DURING THE REMOVAL PROCEDURE. THE ICM HAD EXTENSIVE SCAR TISSUE AROUND IT AND REQUIRED SIGNIFICANT DEBRIDEMENT AND THE INCISION HAD TO BE EXTENDED VERTICALLY SO THAT IT WAS POSSIBLE TO GRAB THE DEVICE. THE ICM WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 24018285 ↗
• MalfunctionDec 16, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED CONNECTIVITY ISSUES. THE DEVICE DID SHOW SOME SIGNAL BUT THEN CONNECTION REPEATEDLY DROPPED BEFORE INTERROGATION. 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 23814715 ↗
• InjuryDec 8, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT SWELLING AND HARDNESS WERE OBSERVED NEAR THE AREA OF THE IMPLANTABLE CARDIAC MONITOR DEVICE. THE PATIENT WAS EVALUATED IN THE EMERGENCY DEPARTMENT, WHERE SOFT TISSUE NECROTIC FAT TISSUE WAS IDENTIFIED NEAR THE DEVICE, WITH NO SIGN OF INFECTION. THE PATIENT WAS TREATED WITH AN ANTIBIOTIC AS A PRECAUTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Necrosis; Swelling/ Edema

  MAUDE report 23742525 ↗
• InjuryDec 1, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT WITH AN IMPLANTABLE CARDIAC MONITOR ICM EXPERIENCED NUMBNESS AND TINGLING AROUND THE IMPLANT SITE. THE ICM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Numbness

  MAUDE report 23678168 ↗
• MalfunctionNov 28, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS NOT DETECTING THE IMPLANTABLE CARDIAC MONITOR DURING TRANSMISSION ATTEMPTS, WITH NO TELE METRY ESTABLISHED. THE PROGRESS BAR DID NOT FILL DURING TRANSMISSION, AND THE MONITOR WAS DISCONNECTED ON NETWORK. AFTER ATTEMPTING TO SEND A TRANSMISSION, THERE WAS NO GREEN BAR OR INDICATION OF TRANSMISSION PROCESS ON THE SCREEN. THE PATIENT RECEIVED A NEW READER, ALLOWED IT TO CHARGE, AND ATTEMPTED TO SEND A TRANSMISSION, BUT THE READER WAS STILL NOT DETECTED. TROUBLESHOOTING STEPS INCLUDED ADJUSTING THE READER POSITION, POWER CYCLING THE MONITOR, USING A DRY WASHCLOTH, REMOVING ELECTROMAGNETIC INTERFERENCE, AND VERIFYING BATTERY STATUS. THE PATIENT CONFIRMED THE PRESENCE OF ELECTRONICS NEARBY BEFORE TRANSMISSION AND REMOVED THEM, BUT THE ISSUE PERSISTED. THE PATIENT WAS REFERRED TO THE CLINIC FOR FURTHER EVALUATION AND WAS INSTRUCTED TO MAKE AN APPOINTMENT, BRING THE MONITOR, AND POSSIBLY HAVE THE DEVICE INTERROGATED IN OFFICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669903 ↗
• MalfunctionNov 27, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS FURTHER REPORTED THAT THE ICM BATTERY WAS NO LONGER FUNCTIONING, HAVING BEEN IMPLANTED IN 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23664805 ↗
• MalfunctionNov 13, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD READER POSITION PROBLEM RESULTING IN NO TELEMETRY WITH THE IMPLANTABLE CARDIAC MONITOR (ICM), A PROGRESS BAR NOT FILLING DURING TRANSMISSION ATTEMPTS, INABILITY TO VIEW BATTERY STATUS ON THE MONITOR, AND NO RECORD OF PREVIOUS TRANSMISSIONS SENT. THE PATIENT POWERED THE MONITOR OFF AND ON UP TO TWO TIMES AND ATTEMPTED TO SEND THE TRANSMISSION MULTIPLE TIMES. TROUBLESHOOTING STEPS INCLUDED ADJUSTING THE READER POSITION, POWER CYCLING THE MONITOR, USING A DRY WASHCLOTH, REMOVING ELECTROMAGNETIC INTERFERENCE, AND MOVING TO ANOTHER ROOM WITH BETTER CELLULAR SERVICE. THE PATIENT WILL BE IN CONTACT WITH THE CLINIC. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543013 ↗
• MalfunctionNov 11, 2025Communication or Transmission Problem; Reset Problem; Communication or Transmission Problem; Reset Problem

  IT WAS REPORTED THAT THE REVEAL LINQ IMPLANTABLE CARDIAC MONITOR WAS ASSOCIATED WITH TROUBLE SENDING TRANSMISSIONS, AND AN IN-OFFICE DEVICE INTERROGATION REVEALED AN ELECTRICAL RESET. THE DEVICE WAS EXPLANTED AND REPLACED WITH A NEW IMPLANTABLE CARDIAC MONITOR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523087 ↗
• MalfunctionNov 11, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD NO TELEMETRY WITH THE IMPLANTABLE CARDIAC MONITOR (ICM) AND THE PATIENT NOT BEING CONNECTED TO THE DEVICE. TESTING WAS PERFORMED BY REMOVING THE UNIVERSAL SERIAL BUS (USB) ADAPTER AND VERIFYING THE CELL SIGNAL FOR DEVICE CONNECTIVITY. THE LACK OF TELEMETRY WAS REFERRED TO THE CLINIC. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522155 ↗
• MalfunctionNov 6, 2025Communication 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 CLINIC FOR A DEVICE CHECK. 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 23484681 ↗
• MalfunctionNov 5, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT WITH AN IMPLANTABLE CARDIAC MONITOR (ICM) WAS UNABLE TO SEND A MANUAL TRANSMISSION USING A NEW MYCARELINK MONITOR. THE PATIENT WAS UNABLE TO CONSISTENTLY TRANSMIT AT THE TIME OF THE CALL, AND THE MONITOR CONNECTION AVAILABILITY WAS LISTED AS DISCONNECTED. THE LAST COMMUNICATION FROM THE DEVICE OCCURRED 1671 DAYS PRIOR. DESPITE GUIDANCE FROM BOTH THE CLINICIAN AND SUPPORT, THE PATIENT REPORT WAS NOT SENT. THE PATIENT OBSERVED A GREEN PROGRESS BAR THAT APPEARED AND DISAPPEARED, BUT NO TRANSMISSION WAS SENT. THE PATIENT CONFIRMED RECEIPT OF THE NEW MONITOR, REPORTED A STRONG CELLULAR SIGNAL AND 4G CONNECTIVITY, AND STATED THAT THE MONITOR WAS POSITIONED NEAR A WINDOW. TROUBLESHOOTING STEPS INCLUDED ADVISING THE PATIENT TO DISCONNECT AND RECONNECT THE MONITOR TO THE WALL OUTLET, CHARGE THE MONITOR IN A DIFFERENT SOCKET FOR ONE HOUR, AND GUIDING THE PATIENT THROUGH THE REPORT SENDING PROCESS. THE PATIENT WAS REFERRED TO THE CLINIC FOR A DEVICE CHECK AND FURTHER ASSISTANCE. A TICKET WAS ALSO CREATED DUE TO THE MONITOR NOT COMMUNICATING STILL AFTER DESPITE ALL THE TROUBLESHOOTING DONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475655 ↗
• MalfunctionSep 10, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING THE SETUP OF THE REMOTE MONITOR, THERE WAS NO TELEMETRY WITH THE IMPLANTABLE CARDIAC MONITOR (ICM), NO PROGRESS BAR, NO BEEPING, AND A READER POSITION ISSUE WAS IDENTIFIED. A POWER CYCLE OF THE MONITOR WAS ATTEMPTED, ELECTRONIC INTERFERENCE WAS CHECKED, AND A DRY WASHCLOTH WAS USED IN TROUBLESHOOTING. THE ISSUE REMAINED UNRESOLVED AND THE PATIENT WAS REFERRED BACK TO THE CLINIC. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23013573 ↗
• MalfunctionAug 19, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD UNSUCCESSFUL DAILY WIRELESS AUDIT (DWA). IT WAS ALSO REPORTED THAT THE REMOTE MONITOR WHITE BAR NEVER APPEARED WHEN ATTEMPTING TO SEND A MANUAL TRANSMISSION WITH THE IMPLANTABLE CARDIAC MONITOR (ICM). THE PATIENT STATED THAT THE MONITOR WAS NOT GETTING ENOUGH SIGNAL TO SEND INFORMATION. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE ISSUE WAS REFERRED TO THE CLINIC. THE PATIENT MANAGEMENT DATABASE CONFIRMED THAT THE REMOTE MONITOR DID NOT HAVE ANY SUCCESSFUL AUTOMATIC TRANSMISSIONS SINCE THE DATE OF THE CALL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22838465 ↗
• MalfunctionJul 18, 2025Reset Problem; Reset Problem

  IT WAS REPORTED THAT AN ELECTRICAL RESET WAS NOTED ON A REVEAL LINQ IMPLANTABLE CARDIAC MONITOR DURING AN IN-OFFICE DEVICE CHECK. THERE WAS AN INABILITY TO CLEAR THE RESET, AND THE DEVICE MIGHT HAVE BEEN AT END OF SERVICE. THE DEVICE REMAINED IMPLANTED. THE PATIENT WAS DISCONTINUED FROM CARELINK. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540251 ↗
• MalfunctionJul 16, 2025Battery Problem; Communication or Transmission Problem; Battery Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT REPRESENTATIVE WAS UNABLE TO OBTAIN TELEMETRY ON THE REMOTE MONITOR WITH THE MYCARELINK SYSTEM FOR THE IMPLANTABLE CARDIAC MONITOR. THE PATIENT REPRESENTATIVE ATTEMPTED A MANUAL TRANSMISSION BUT DID NOT RECEIVE TELEMETRY. TROUBLESHOOTING STEPS INCLUDED POWER CYCLING THE MONITOR, CHECKING FOR POSSIBLE INTERFERENCE IN THE PATIENT ROOM, AND CONFIRMING THE PATIENT WAS IN A NURSING FACILITY. IT WAS DETERMINED THAT THERE WAS NO INTERFERENCE PRESENT. THE DIAGNOSTICS DEPARTMENT WAS CONTACTED AND CONFIRMED THAT THE DEVICE HAD REACHED END OF SERVICE (EOS) AND THE PATIENT HAD NEVER TRANSMITTED DATA. THE PATIENT WAS REFERRED TO A CLINIC FOR FURTHER EVALUATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22517696 ↗
• MalfunctionJul 11, 2025Communication 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 INCLUDED ADJUSTING THE POSITION OF THE READER, POWER CYCLING THE MONITOR, PLACING A DRY WASHCLOTH BETWEEN THE READER AND THE IMPLANT, AND REMOVING ANY SOURCES OF INTERFERENCE WITHIN SIX FEET SUCH AS MAJOR ELECTRONICS, CELL PHONES, BLUETOOTH DEVICES, SMART DEVICES, AND RADIOS, FOLLOWED BY REATTEMPTING THE TRANSMISSION AFTER REMOVING ELECTROMAGNETIC INTERFERENCE. THE PATIENT WAS REFERRED TO THE CLINIC.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22477850 ↗
• MalfunctionJul 9, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR DISPLAYED A 7332 DIAGNOSTIC CODE. ALSO, IT HAD NO TELEMETRY WITH THE IMPLANTABLE CARDIAC MONITOR (ICM). THE MONITOR WAS POWER CYCLED FOR THE ERROR CODE, AND FOR THE LACK OF TELEMETRY, THE PATIENT WAS REFERRED TO THE CLINIC. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455870 ↗
• MalfunctionJul 8, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD NO TELEMETRY WITH THE IMPLANTABLE CARDIAC MONITOR (ICM). THE MONITOR HAS BEEN PLUGGED IN ALL THE TIME AND SHOWED 4G. ATTEMPTED TO SEND A TRANSMISSION AND A DIAGNOSTIC CODE APPEARED BUT IT SELF CLEARED. A TRANSMISSION WAS ATTEMPTED BUT WAS NOT SHOWING THE PROGRESS BAR. FOLLOWED TROUBLESHOOTING FOR NO TELEMETRY. THE PATIENT WILL WORK WITH THE CLINIC FOR A DEVICE CHECK, ADVISED TO GO TO THE APPOINTMENT WITH THE MONITOR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435540 ↗
• MalfunctionJun 26, 2025Failure to Interrogate; Over-Sensing; Under-Sensing; Battery Problem; Failure to Interrogate; Over-Sensing; Under-Sensing; Battery Problem

  IT WAS NOTED IN THE RECENT IMPLANTABLE CARDIAC MONITOR (ICM) TRANSMISSION THAT THE ICM HAD EXPERIENCED OVERSENSING ON A TACHYCARDIA EPISODE. IT WAS FURTHER NOTED THAT THE ICM EXPERIENCED UNDERSENSING ON A PAUSE EPISODE. IT WAS ALSO REPORTED THAT DIFFICULTIES WERE ENCOUNTERED WHEN INTERROGATING THE ICM, THE INCORRECT APPLICATION MAY HAVE BEEN USED. THE ICM HAD REACHED END OF SERVICE (EOS). 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 22335711 ↗
• MalfunctionJun 24, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WAS A READER POSITION ISSUE RESULTING IN NO TELEMETRY WITH THE IMPLANTABLE CARDIAC MONITOR (ICM) AND MYCARELINK. THE POSITION OF THE READER WAS ADJUSTED, THE MONITOR WAS POWER CYCLED, THE READER WAS PLACED OVER CLOTHES, AND INTERFERENCES WERE REMOVED. THE PATIENT WAS REFERRED TO CLINIC. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318971 ↗
• MalfunctionJun 24, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT AN ISSUE OCCURRED WITH THE IMPLANTABLE CARDIAC MONITOR (ICM) INVOLVING NO TELEMETRY WITH MYCARELINK REMOTE MONITOR. MULTIPLE ATTEMPTS TO SEND A MANUAL TRANSMISSION WERE UNSUCCESSFUL, AND THERE WAS NO PROGRESS BAR OR GREEN BAR FILLING ON THE INTERFACE. TROUBLESHOOTING STEPS INCLUDED ADJUSTING THE RADIOFREQUENCY READER POSITION, PERFORMING A POWER CYCLE, USING A WASHCLOTH TO IMPROVE CONTACT, CHECKING FOR ELECTROMAGNETIC INTERFERENCE. THE PATIENT WAS REFERRED TO A CLINIC TO VERIFY BATTERY STATUS AND CONSIDER POSSIBLE REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318810 ↗