PROPONENT™ EL DR L221Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00802526559112), received between Jan 22, 2019 and May 17, 2023 — classified as 21 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE WAS SUSPECTED OF EXHIBITING PREMATURE BATTERY DEPLETION BEHAVIOR. DURING A RECENT FOLLOW-UP VISIT, THE ESTIMATED BATTERY LONGEVITY SHOWED ONE YEAR REMAINING. A DEVICE REPLACEMENT PROCEDURE HAS BEEN SCHEDULED. THIS DEVICE CURRENTLY REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16945670 ↗
• InjuryFeb 16, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE WAS SUSPECTED OF EXHIBITING PREMATURE BATTERY DEPLETION BEHAVIOR. A DECREASE IN THE ESTIMATED BATTERY LONGEVITY WAS OBSERVED BETWEEN FOLLOW-UP VISITS. THE MOST RECENT ESTIMATED BATTERY LONGEVITY IS SHOWING 3.5 YEARS REMAINING. THIS DEVICE CURRENTLY REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386108 ↗
• InjuryFeb 9, 2023Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER PRESENTED TO A DEVICE CHECK AFTER EXPERIENCING A SYNCOPAL EPISODE. HOWEVER, THE DEVICE WAS NOT ABLE TO BE INTERROGATED AFTER MULTIPLE ATTEMPTS WITH SEVERAL PROGRAMMERS. AT A DEVICE CHECK SIX MONTHS PRIOR, THE REMAINING BATTERY WAS 10 YEARS. THE PATIENT WAS ADMITTED AND THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED DEVICE WAS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Syncope/Fainting

  MAUDE report 16333907 ↗
• MalfunctionDec 19, 2022Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS DEVICE WAS SUSPECTED OF EXHIBITING PREMATURE BATTERY DEPLETION BEHAVIOR. A SIGNIFICANT DECREASE IN THE ESTIMATED BATTERY LONGEVITY WAS OBSERVED BETWEEN FOLLOW-UP VISITS. THE PATIENT WILL CONTINUE BEING MONITORED. IT IS ANTICIPATED THAT A REPLACEMENT PROCEDURE WILL BE PERFORMED IN SIX MONTHS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION: A GOOD FAITH EFFORT WAS SUBMITTED TO THE FIELD TO OBTAIN FURTHER INFORMATION. THE FIELD REPRESENTATIVE DID NOT HAVE ANY NEW INFORMATION TO PROVIDE AND INDICATED THAT THEY NEEDED TO FOLLOW-UP WITH THE PATIENT'S PHYSICIAN IN ORDER TO OBTAIN ADDITIONAL DETAILS REGARDING THE STATUS OF THIS DEVICE. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16006734 ↗
• MalfunctionApr 9, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PATIENT WAS SEEN FOR A FOLLOW UP AFTER NOT BEING SEEN FOR TWO YEARS. THE LAST INTERROGATION OF THIS DEVICE IN (B)(6) 2020 SHOWED AN ESTIMATED BATTERY OF 10.5 YEARS, WHILE MOST RECENTLY THE BATTERY SHOWED 7.5 YEARS BATTERY REMAINING. A REQUEST FOR DEVICE DATA REVIEW WAS NEEDED. A REVIEW BY ENGINEERING CONFIRMED THAT THE DEVICE WAS EXHIBITING MODERATE ACCELERATION IN THE RATE OF BATTERY DEPLETION AND THE DEVICE SHOULD BE REPLACED AND RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14068605 ↗
• InjuryApr 9, 2022Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE DEVICE WAS SUSPECTED TO BE EXHIBITING PREMATURE BATTERY DEPLETION BEHAVIOR. A DECREASE IN THE ESTIMATED BATTERY LONGEVITY WAS OBSERVED DURING A RECENT FOLLOW-UP VISIT. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE IS EXPECTED FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14068454 ↗
• InjuryApr 9, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER WAS DEPLETING FASTER THAN EXPECTED. WHEN IMPLANTED IN 2017, THE DEVICE HAD AN ESTIMATED LONGEVITY BASED ON PROGRAMMING PARAMETERS OF 11.5 YEARS BUT THERE IS CURRENTLY 11 MONTHS OF ESTIMATED LONGEVITY REMAINING ONLY 5 YEARS LATER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14067951 ↗
• InjuryOct 22, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP, THIS DEVICE EXHIBITED SAFETY MODE OPERATION. NO RESULTING ADVERSE PATIENT EFFECTS WERE REPORTED AND ALL ATTEMPTS TO OBTAIN RESOLUTION WERE UNSUCCESSFUL. THE DEVICE WAS LATER EXPLANTED AND RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12686510 ↗
• InjuryOct 17, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT A REQUEST FOR DATA REVIEW WAS NEEDED DUE TO A DECREASE IN THE BATTERY OF THIS DEVICE FROM EIGHT YEARS TO FIVE AND A HALF YEARS AT THE NINE MONTH FOLLOW UP INTERVAL. A REVIEW OF THE DEVICE DATA BY TECHNICAL SERVICES (TS) CONFIRMED THAT THE DEVICE WAS EXHIBITING MODERATE ACCELERATION IN THE RATE OF BATTERY DEPLETION. TS CONFIRMED THE POWER CONSUMPTION WAS INCREASING DURING THE PAST YEAR AND WAS EXPECTED TO CONFIRM TO INCREASE. THE DEVICE SHOULD BE EXPLANTED AND REPLACED. TS ALSO NOTED THAT ASSUMING THE DEVICE BEHAVIOR REMAINS UNCHANGED THERE WAS SUFFICIENT BATTERY CAPACITY TO SUPPORT THERAPY AND REPLACEMENT FOR AT LEAST NINETY DAYS. THE DEVICE WAS EXPLANTED AND WILL BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12644365 ↗
• MalfunctionOct 12, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY OF THIS PACEMAKER WAS SUSPECTED TO BE PREMATURELY DEPLETING. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME AND THE PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12620555 ↗
• InjuryJul 2, 2021Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE DEVICE WAS SUSPECTED TO BE DEPLETING PREMATURELY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED WITHIN THE NEXT 90 DAYS. THE RETURN TO BOSTON SCIENTIFIC FOR ANALYSIS, POST EXPLANT WAS RECOMMENDED. TO DATE THIS DEVICE REMAINS IMPLANTED AND IN SERVICE WITH NO RESULTING ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112480 ↗
• InjuryApr 14, 2021Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP, THIS DEVICE WAS UNABLE TO BE SUCCESSFULLY INTERROGATED. IT WAS ADDITIONALLY STATED THE PATIENT COMPLAINED OF DISCOMFORT. THE DEVICE WAS ALSO UNRESPONSIVE TO MAGNET APPLICATION AND HAS BEEN SCHEDULED FOR REPLACEMENT. THE DATE WAS NOT KNOWN AND THE PATIENT DISCHARGED AT THIS TIME. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED ABOUT TEN DAYS LATER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Discomfort

  MAUDE report 11668666 ↗
• InjuryJan 6, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING A ROUTINE DEVICE FOLLOW-UP, THIS PACEMAKER SHOWED A REMAINING LONGEVITY OF 3 MONTHS. THE DEVICE HAD ONLY BEEN IMPLANTED FOR THREE YEARS, SO PREMATURE BATTERY DEPLETION WAS SUSPECTED. DEVICE DATA WAS SUBMITTED TO TECHNICAL SERVICES FOR REVIEW. ENGINEERING ANALYSIS CONFIRMED AN ABNORMAL INCREASE IN THE POWER CONSUMPTION AND DEVICE REPLACEMENT WAS RECOMMENDED FOR WITHIN 90 DAYS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE, PENDING A REPLACEMENT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11128078 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER PRESENTED WITH EROSION/EXTRUSION OF THE DEVICE. INFECTION WAS LIKELY BUT NOT CONFIRMED. THE PACEMAKER AND NON-BOSTON SCIENTIFIC LEADS WERE EXPLANTED AND A NEW SYSTEM WAS IMPLANTED ON THE PATIENT'S RIGHT SIDE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Erosion; No Code Available; Unspecified Infection

  MAUDE report 10775447 ↗
• MalfunctionOct 20, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT THERE WAS AN INQUIRY INTO THE BATTERY LONGEVITY OF THIS PACEMAKER. REVIEW OF THE DEVICE DATA CONFIRMED THERE HAVE BEEN INTERMITTENT INCREASES IN POWER CONSUMPTION THAT ARE A RESULT OF HIGH RATE ATRIAL SENSING ASSOCIATED WITH ATRIAL TACHYCARDIA EVENTS. THE PACEMAKER IS OPERATING NORMALLY AND REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10707926 ↗
• InjuryJul 21, 2020Signal Artifact/Noise; Premature Discharge of Battery; Over-Sensing; Signal Artifact/Noise; Premature Discharge of Battery; Over-Sensing

  IT WAS REPORTED THAT THIS PACEMAKER SHOWED A REMAINING LONGEVITY OF THREE YEARS. PREMATURE BATTERY DEPLETION WAS SUSPECTED AND DEVICE DATA WAS SUBMITTED TO TECHNICAL SERVICES FOR EVALUATION. UPON REVIEW, IT WAS CONFIRMED THE DEVICE WAS EXHIBITING AN INCREASE IN POWER CONSUMPTION AND DEVICE REPLACEMENT WAS RECOMMENDED FOR WITHIN 90 DAYS. TECHNICAL SERVICES ALSO NOTED THERE WAS OVERSENSING OF NOISE ON THE RIGHT ATRIAL (RA) CHANNEL. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 10306128 ↗
• InjuryJul 20, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING A ROUTINE DEVICE FOLLOW-UP, THE REMAINING LONGEVITY ON THIS PACEMAKER WAS LESS THAN EXPECTED. AT THE PREVIOUS DEVICE CHECK IN (B)(6) 2020 THE REMAINING LONGEVITY WAS 5 YEARS AND CURRENTLY IT WAS 3.5 YEARS. PREMATURE BATTERY DEPLETION WAS SUSPECTED AND THE PHYSICIAN INTENDED TO REPLACE THE DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE PENDING A REPLACEMENT PROCEDURE.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 10299645 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND EROSION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 10233894 ↗
• InjuryApr 9, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER ESTIMATED LONGEVITY DECREASED FROM NINE YEARS TO FOUR YEARS WITHIN THIRTEEN MONTHS. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS SHOWED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PHYSICIAN HAS ELECTED TO MONITOR THE PATIENT MORE FREQUENTLY UNTIL ELECTIVE REPLACEMENT TIME (ERT) NEARS. NEW INFORMATION RECEIVED INDICATES THAT THIS DEVICE WAS EXPLANTED. THE EXPLANTED DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 9946961 ↗
• InjuryApr 9, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE WAS DEPLETING FASTER THAN EXPECTED. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS SHOWED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9944843 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PACEMAKER HAD ERODED THROUGH THE DEVICE POCKET. THERE WERE NO SIGNS OF INFECTION, AND THE DEVICE AND ASSOCIATED LEADS WERE EXPLANTED AND REPLACED WITH A NEW SYSTEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 9623730 ↗
• MalfunctionOct 17, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PACEMAKER STOPPED WORKING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WAS UNSUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9204478 ↗
• InjuryOct 15, 2019High impedance; Over-Sensing; Connection Problem; Device Sensing Problem; High impedance; Over-Sensing; Connection Problem; Device Sensing Problem

  IT WAS REPORTED THAT THIS PACEMAKER DETECTED HIGH OUT-OF-RANGE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE MEASUREMENTS AND EVIDENCE OF OVERSENSED NOISE. ISOMETRICS WERE SUCCESSFUL IN RE-CREATING THE NOISE. AN X-RAY CONFIRMED AN UNDER INSERTED LEAD. SURGICAL INTERVENTION WAS PERFORMED TO RESOLVE THE CONNECTION ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9193409 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS DEVICE SYSTEM PRESENTED AT FOLLOW-UP WITH A NOTABLE POCKET INFECTION. THE PATIENT WAS SENT HOME WITH ANTIBIOTICS AND RETURNED LATER FOR A SYSTEM EXTRACTION AND REPLACEMENT. NO ADDITIONAL ADVERSE EFFECTS WERE OBSERVED AND THE PATIENT REPORTED AS STABLE POST REVISION. NO RETURN OF ANY PRODUCT IS EXPECTED.

  Patient problems: Unspecified Infection

  MAUDE report 8799049 ↗
• InjuryJun 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS DEVICE PRESENTED WITH A FEVER. THE PATIENT WAS HOSPITALIZED AND DIAGNOSED BY TRANS-ESOPHAGEAL ECHOCARDIOGRAM, WITH BACTERIAL ENDOCARDITIS. THE PHYSICIAN STATED THE SYSTEM REQUIRED EXPLANT HOWEVER, NO INFORMATION WAS PROVIDED REGARDING THE SYSTEM LEAD MANUFACTURE AND THE DEVICE WAS LATER REPORTED AS EXPLANTED. FOLLOWING ANTIBIOTIC TREATMENT AND A NORMAL ECHOCARDIOGRAM, A NEW BICAMERAL PACEMAKER IMPLANT WILL BE SCHEDULED. NO ALLEGATIONS AGAINST THE BOSTON SCIENTIFIC PRODUCT WERE MADE.

  Patient problems: Endocarditis; Fever

  MAUDE report 8720339 ↗