ESSENTIO™ SR L100Recalls & reported problems

Summary

The FDA's MAUDE database contains 387 adverse event reports that list this exact device (DI 00802526558900), received between Apr 22, 2016 and Aug 17, 2026 — classified as 3 deaths, 276 injuries, 108 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (208 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 20, 2025Open, Classified

   Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

   Z-0079-2026 · Root cause: Other · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 387 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker had entered safety mode. Technical Services (TS) was consulted and recommended device replacement. This pacemaker has been explanted. No additional adverse patient effects were reported. This product has been returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50278457 ↗
• MalfunctionJun 24, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER RECORDED A CODE 1003, INDICATING THE VOLTAGE IS TOO LOW FOR THE PROJECTED REMAINING CAPACITY. DATA ANALYSIS IDENTIFIED POTENTIAL HIGH IMPEDANCE WITHIN THE BATTERY. CONTINUED MONITORING WAS RECOMMENDED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25612093 ↗
• MalfunctionMay 29, 2026Premature Discharge of Battery; Use of Device Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED DIFFICULTIES TO INTERROGATE. TECHNICAL SERVICES (TS) PERFORMED FURTHER ANALYSIS AND DETERMINED THAT THE DEVICE HAD RECORDED A TRUE POSITIVE REMOTE MONITORING DISABLED (RMD) ALERT FOR RADIO FREQUENCY (RF) TELEMETRY DUE TO A LOW LOADED BATTERY VOLTAGE MEASUREMENT. DEVICE REPLACEMENT WAS RECOMMENDED, AND THE FINDINGS WERE COMMUNICATED TO THE HEALTH CARE PROFESSIONAL (HCP). NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340674 ↗
• InjuryApr 17, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE RECORDED A CODE 1003, INDICATING THE VOLTAGE IS TOO LOW FOR THE PROJECTED REMAINING CAPACITY. DATA ANALYSIS IDENTIFIED POTENTIAL HIGH IMPEDANCE WITHIN THE BATTERY. A DEVICE REPLACEMENT TIMELINE WAS CREATED. THE DEVICE WILL REMAIN IMPLANTED AND THE PATIENT WILL BE MONITORED AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910227 ↗
• InjuryApr 9, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE RECORDED A CODE 1003, WHICH STATES THAT THE VOLTAGE IS TOO LOW FOR PROJECTED REMAINING CAPACITY. IT WAS REPORTED THAT A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS IDENTIFIED POTENTIAL HIGH IMPEDANCE WITHIN THE BATTERY. DEVICE REPLACEMENT WAS RECOMMENDED. THIS DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831781 ↗
• InjuryMar 18, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT THIS IMPLANTABLE PACEMAKER RECORDED A CODE 1003, WHICH STATES THAT THE VOLTAGE IS TOO LOW FOR PROJECTED REMAINING CAPACITY. THE DEVICE HAS BEEN EXPLANTED AT THIS TIME AND HAS NOT YET BEEN RETURNED FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634959 ↗
• MalfunctionMar 17, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT THIS IMPLANTABLE PACEMAKER RECORDED A CODE 1003, WHICH STATES THAT THE VOLTAGE IS TOO LOW FOR PROJECTED REMAINING CAPACITY. NO OTHER INFORMATION WAS PROVIDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618793 ↗
• InjuryFeb 18, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE RECORDED A CODE 1003, WHICH STATES THAT THE VOLTAGE IS TOO LOW FOR PROJECTED REMAINING CAPACITY. IT WAS REPORTED THAT A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS IDENTIFIED POTENTIAL HIGH IMPEDANCE WITHIN THE BATTERY. DEVICE REPLACEMENT WAS RECOMMENDED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED, AND THIS DEVICE HAS NOT BEEN RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24382265 ↗
• MalfunctionFeb 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) REVERTED INTO SAFETY MODE. THIS DEVICE WAS CONFIRMED TO BE IN SAFETY MODE AND DEVICE REPLACEMENT WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-P REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335040 ↗
• MalfunctionJan 14, 2026Data Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED AN ALERT MESSAGE INDICATING THAT BATTERY REPLACEMENT INDICATOR HAD BEEN REACHED ON JANUARY 1, 2000 AND THAT REMOTE MONITORING WAS DISABLED. ANALYSIS OF DEVICE DATA WAS REQUESTED. TECHNICAL SERVICES DISCUSSED THAT THIS WAS A FALSE POSITIVE EXPLANT INDICATOR RELATED TO A SOFTWARE UPDATE AND THAT ALL OTHER DEVICE FUNCTIONS REMAIN AVAILABLE. ADDITIONALLY, IT WAS NOTED THAT THE BATTERY STATUS IS AT BEGINNING OF LIFE AND THAT DUE TO THE ELECTIVE REPLACEMENT INDICATOR (ERI) VALUES NOT BEEN SET, THE NUMBER ZERO IS CAUSING THE DATE TO SHOW AS JANUARY 1, 2000. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068492 ↗
• MalfunctionJan 9, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER RECORDED A CODE 1003, WHICH STATES THAT THE VOLTAGE IS TOO LOW FOR PROJECTED REMAINING CAPACITY. DATA ANALYSIS IDENTIFIED POTENTIAL HIGH IMPEDANCE WITHIN THE BATTERY. DEVICE REPLACEMENT WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND THE DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020376 ↗
• MalfunctionDec 29, 2025Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS UNABLE TO BE INTERROGATED WITH WAND. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION OBTAINED, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION (NBD). THE DEVICE WAS NOT ABLE TO BE INTERROGATED DUE TO BEING IN END OF LIFE (EOL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23910911 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23361174 ↗
• MalfunctionSep 2, 2025Premature Discharge of Battery; High impedance; Over-Sensing; Battery Problem; Premature Discharge of Battery; High impedance; Over-Sensing; Battery Problem

  IT WAS REPORTED THAT DURING A CLINIC VISIT, THE HEALTH CARE PROFESSIONAL (HCP) SUSPECTED OF THIS PACEMAKER BATTERY TO BE DEPLETING PREMATURELY DUE TO THE BATTERY LONGEVITY ESTIMATE CALCULATIONS HAD DECREASED FROM TWO YEARS TO ONE YEAR IN ABOUT SIX MONTHS. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. TECHNICAL SERVICES (TS) REVIEWED THE STORED DEVICE DATA AND NOTED THAT A LEAD SAFETY SWITCH (LSS) TO UNIPOLAR CONFIGURATIONS WAS TRIGGERED DUE TO HIGH OUT OF RANGE PACING IMPEDANCES ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO NOTED THE LEAD EXHIBITED OVERSENSING AS WELL. ENGINEERING ANALYZED THE DATA AND DETERMINED THAT THE DEVICE BATTERY WAS DEPLETING NORMALLY, AND THE INCREASE IN POWER CONSUMPTION APPEARS TO BE DUE TO BE DUE TO THE INCREASE IN PACING IMPEDANCES ON THE RV LEAD. AT THIS TIME, THE PACEMAKER AND RV LEAD REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939529 ↗
• DeathJul 7, 2025Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER ENTERED SAFETY MODE, RESULTING IN PACING INHIBITION AND MULTIPLE SYNCOPAL EPISODES. THE PATIENT FELL AND SUSTAINED A SPINAL FRACTURE, AND CHEST COMPRESSIONS WERE ADMINISTERED DUE TO PAUSES SEEN ON TELEMETRY. THIS DEVICE WAS EXPLANTED AND REPLACED. THIS DEVICE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Fall; Syncope/Fainting; Vertebral Fracture

  MAUDE report 22414182 ↗
• InjuryJun 3, 2025Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem; Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER COULD NOT BE INTERROGATED DUE TO POSSIBLE LOW BATTERY AS THE DEVICE WAS IMPLANTED FOR ABOUT 10 YEARS. THE PATIENT SHOWED UP IN THE EMERGENCY ROOM WITH A HEART RATE OF 27 BEATS PER MINUTE. THE FIELD REPRESENTATIVE WAS STILL NOT ABLE TO INTERROGATE THE DEVICE AND GOT A RED SCREEN FOR VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY IN STORAGE MODE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND REPLACED WITH A NEW DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22135390 ↗
• MalfunctionMay 20, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PACEMAKER WAS RECEIVED BY POST MARKET QUALITY ASSURANCE FOR ANALYSIS WITHOUT ALLEGATION FROM THE FIELD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057601 ↗
• MalfunctionApr 23, 2025Defective Device; Defective Device

  THIS PRODUCT WAS RETURNED TO THE MANUFACTURER WITHOUT ANY REPORT OF PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. THE RETURNED DEVICE WAS ANALYZED AND INITIAL INVESTIGATION NOTED A FAILED LONGEVITY CALCULATION. DETAILED ANALYSIS CONFIRMED PREMATURE BATTERY DEPLETION DUE TO HIGH HYDROGEN INDUCED LEAKY CAPACITORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891558 ↗
• InjuryDec 13, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER WAS EXPLANTED DUE TO NON-SPECIFIC PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20922091 ↗
• InjuryNov 13, 2024Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. IT WAS REPORTED THAT A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS SHOWED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. TECHNICAL SERVICES (TS) RECOMMENDED THAT THE DEVICE EITHER GET REPLACED OR HAVE BATTERY STATUS RE-REVALUATED IN NINETY DAYS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675215 ↗
• MalfunctionSep 11, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER DEVICE WAS RECEIVED BY POST MARKET QUALITY ASSURANCE WITHOUT A KNOWN REASON FOR EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20193037 ↗
• InjuryAug 15, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER EXHIBITED PREMATURE BATTERY DEPLETION (PBD). A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. ALSO, THIS DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). TECHNICAL SERVICES (TS) CONSULTANT RECOMMENDED REPLACEMENT. THIS S-ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991277 ↗
• MalfunctionAug 8, 2024Defective Device; Defective Device

  THIS PRODUCT WAS RETURNED TO THE MANUFACTURER WITHOUT ANY REPORT OF PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. THE RETURNED DEVICE WAS ANALYZED AND INITIAL INVESTIGATION NOTED A FAILED LONGEVITY CALCULATION. DETAILED ANALYSIS CONFIRMED PREMATURE BATTERY DEPLETION DUE TO HIGH HYDROGEN INDUCED LEAKY CAPACITORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937535 ↗
• InjuryJun 18, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM WAS EXPLANTED DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION WAS AVAILABLE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563713 ↗
• MalfunctionJun 1, 2024Defective Device; Defective Device

  THIS PRODUCT WAS RETURNED TO THE MANUFACTURER WITHOUT ANY REPORT OF PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. THE RETURNED DEVICE WAS ANALYZED, AND THE PRODUCT INVESTIGATION RESULT INDICATED THAT THIS DEVICE EXHIBITED HYDROGEN INDUCED PREMATURE BATTERY DEPLETION. SEE H10, FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444346 ↗