ADVANTIO™ K063Recalls & reported problems

Summary

The FDA's MAUDE database contains 557 adverse event reports that list this exact device (DI 00802526516702), received between Apr 22, 2016 and Apr 23, 2026 — classified as 2 deaths, 281 injuries, 274 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (108 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 557 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE PACEMAKER WAS SUSPECTED TO EXHIBIT PREMATURE BATTERY DEPLETION WITH A LONGEVITY DROP FROM 1.5 YEARS TO 5 MONTHS WITHIN A SPAN OF 6 MONTHS. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE DEVICE IS DEPLETING NORMALLY. THE BATTERY WAS OUTPERFORMING THE NOMINAL MODEL. THE LONGEVITY HAS EXCEEDED EXPECTATIONS. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THIS PATIENT WITH A PACEMAKER EXPERIENCED A SYNCOPAL EPISODE. THE CAUSE OF THE SYNCOPAL EVENT WAS UNABLE TO BE DETERMINED. IT WAS NOTED THIS PACEMAKER REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). TECHNICAL SERVICES (TS) ANALYZED THE DATA AND NOTED THERE WERE NO OUT OF RANGE MEASUREMENTS. THIS PACEMAKER WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER HAS NOT BEEN RETURNED FOR ANALYSIS.

  Patient problems: Syncope/Fainting

  MAUDE report 24967594 ↗
• MalfunctionApr 7, 2026Interrogation Problem

  IT WAS DISCOVERED THAT THIS PACEMAKER WAS UNABLE TO BE INTERROGATED USING A COMMUNICATOR. TECHNICAL SERVICES (TS) WAS CONTACTED AND PROVIDED TROUBLESHOOTING OPTIONS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24805285 ↗
• MalfunctionJan 15, 2026Premature Discharge of Battery; Data Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED A FAILURE DURING INTERROGATION IN WHICH DATA COULD NOT BE READ. ADDITIONALLY, THE PATIENT STATED THAT THEIR BATTERY WAS DEAD. TECHNICAL SERVICES (TS) RECOMMENDED FOLLOW-UP WITH A LOCAL BOSTON SCIENTIFIC REPRESENTATIVE. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE REACHED END OF LIFE AS OF (B)(6) 2025 AS A RESULT OF NORMAL BATTERY DEPLETION. THE PATIENT WILL BE SCHEDULED FOR A FUTURE DEVICE REPLACEMENT. AT THIS TIME THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24082284 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS PART OF THE SYSTEM REVISION DUE TO INFECTION AND POCKET REDNESS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 24031942 ↗
• InjuryAug 13, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE PACEMAKER DROPPED FROM 2.5 YEARS TO 8 MONTHS IN A SPAN OF 9 MONTHS. ALSO, NON-SUSTAINED EPISODES APPEARED TO BE ALERTING ALMOST DAILY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THAT THE BATTERY APPEARED TO BE DEPLETING NORMALLY. FURTHERMORE, THE LONGEVITY HAS EXCEEDED EXPECTATIONS AS THE BATTERY WAS OUTPERFORMING THE NOMINAL MODEL. THE LABELED REPLACEMENT RECOMMENDATIONS OF THE DEVICE APPLY. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791326 ↗
• InjuryAug 8, 2025Battery Problem; Migration; Battery Problem; Migration

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER SHOWED AN ELECTIVE REPLACEMENT INDICATOR (ERI) UP TO 3 MONTHS BEFORE THE END OF LIFE (EOL). THE PATIENT STATED THAT THE DEVICE TRAVELED UP TO THE COLLAR BONE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ADDED THAT WILL CONTINUE TO FOLLOW UP WITH HEALTH CARE PROFESSIONAL (HCP) AND THE SURGERY WILL PLACE A NEW DEVICE UNDER THE MUSCLE. THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THIS PACEMAKER WAS EXPLANTED. A NEW DEVICE WITH A DIFFERENT MODEL WAS SUCCESSFULLY IMPLANTED. ADDITIONALLY, THE PHYSICIAN STATED THAT THE DEVICE HAD NOT MIGRATED. THE DEVICE WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751805 ↗
• MalfunctionAug 5, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER HAD REACHED BATTERY CAPACITY DEPLETED (BCD) FROM ONE YEAR REMAINING. BOSTON TECHNICAL SERVICES CONSULTANT DISCUSSED BCD PARAMETERS AND THAT THERAPY CAN NO LONGER BE GUARANTEED. HEALTH CARE PROFESSIONAL ALSO REPORTED THAT PATIENT WAS COMPLAINING OF FLUTTERING AND WILL SEND THE PATIENT TO THE EMERGENCY ROOM. AS OF THIS TIME, THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715580 ↗
• MalfunctionJun 30, 2025Signal Artifact/Noise; Failure to Capture; Over-Sensing; Pacing Problem; Defective Device; High Capture Threshold; Signal Artifact/Noise; Failure to Capture; Over-Sensing; Pacing Problem; Defective Device; High Capture Threshold

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED NOISE AND OVERSENSING IN THE RIGHT VENTRICULAR (RV) CHANNEL. THIS NOISE REOCCURRED WHILE THE PATIENT WAS SITTING IN THE CHAIR. POSSIBLE REPROGRAMMING WAS DISCUSSED. A REVIEW OF ANOTHER EPISODE NOTED POSSIBLE LOSS OF CAPTURE. SUBSEQUENTLY, THE RV LEAD EXHIBITED PACING INHIBITION AND HIGH CAPTURE THRESHOLDS, THIS LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED; THIS PACEMAKER WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION AND SUCCESSFULLY REPLACED. THIS PACEMAKER WAS LATER RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358419 ↗
• MalfunctionJun 16, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THIS DEVICE HAD EVIDENCE OF UNDERSENSING ON THE STORED ATRIAL INTRACARDIAC ELECTROGRAM. TECHNICAL SERVICES (TS) RECOMMENDED DEVICE OPTIMIZATION FOR THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NEW INFORMATION RECEIVED INDICATES THAT THIS DEVICE WAS EXPLANTED NINE MONTHS LATER FOR NORMAL BATTERY DEPLETION. THE DEVICE WAS RETURNED 19 MONTHS POST EXPLANT FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211452 ↗
• InjuryMay 16, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT PATIENT WITH THIS IMPLANTABLE PACEMAKER EXPERIENCED CHEST PAINS AND GETTING LOW DOSE VIBRATING. ALSO, PATIENT STATED THAT SOMEONE IS TAMPERING WITH THE PACEMAKER, AND SIGNAL CANNOT WORK WHEN HAVING SERIOUS EPISODES. TO DATE, THIS DEVICE REMAINS IN SERVICE. ADDITIONAL INFORMATION INDICATED THAT THIS DEVICE WAS EXPLANTED, AND A NEW DEVICE WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION FROM PATIENT STATING THE DEVICE IMPLANT WAS NOT WORKING AS PATIENT HAD LIFE THREATENING ARRHYTHMIA. PATIENT EXPERIENCED HEART ATTACKS, AND THE DEVICE DID NOT DO ANYTHING. PATIENT HAS "BEEN HAVING A LOT OF PROBLEMS" AND THE PACEMAKER HAS NOT BEEN "KICKING IN" OR CONTROLLING THE HEARTBEAT.

  Patient problems: Arrhythmia; Pain

  MAUDE report 22039459 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED DUE TO AN UNSPECIFIED OTHER OBSERVATION/COMPLICATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.ADDITIONAL INFORMATION FROM THE FIELD INDICATES THIS DEVICE WAS REMOVED AT THE PHYSICIANS DISCRETION IN ORDER FOR THE PATIENT TO HAVE A MAGNETIC RESONANCE IMAGING (MRI) CONDITIONAL SYSTEM IMPLANTED, WERE PREVIOUSLY IT WAS NOT, DUE TO THE USE OF NON BOSTON SCIENTIFIC LEADS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919022 ↗
• InjuryMar 25, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER SYSTEM VISITED THE HOSPITAL AFTER A SYNCOPAL EPISODE. THE HEALTH CARE PROFESSIONAL (HCP) INTERROGATED THE DEVICE NOTING THAT IT HAD REACHED END OF LIFE (EOL) STATUS AND THE PATIENT TO BE IN ASYSTOLE. THE HCP MADE A CONSULT CALL TO TECHNICAL SERVICES (TS) AND REQUESTED FURTHER REVIEW OF THE DEVICE STORED DATA. FURTHER REVIEW OF THE PRESENTING ELECTROGRAM (EGM) SHOWED A LEAD SAFETY SWITCH (LSS) WAS TRIGGERED WHICH CHANGED RIGHT VENTRICULAR (RV) LEAD SETTINGS FROM BIPOLAR TO UNIPOLAR CONFIGURATIONS DUE TO HIGH OUT OF RANGE RV LEAD PACING IMPEDANCES RECORDED TO HAVE BEEN GREATER THAN 2000 OHMS. IT WAS NOTED THAT THE RV LEAD IS A NON-BOSTON SCIENTIFIC PRODUCT. THE HCP SUSPECTED POSSIBLE CAUSE TO BE A SPRING CONTACT ISSUE. TS DISCUSSED REPROGRAMMING OPTIONS WITH THE HCP AND REFERRED THEM TO THE LOCAL FIELD REPRESENTATIVE. THE HCP NOTED THAT THE PHYSICIAN HAS SCHEDULED A DEVICE REPLACEMENT PROCEDURE DUE TO DEVICE REACHING EOL STATUS. AT THIS TIME, THE PACEMAKER AND RV LEAD REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THAT THIS PACEMAKER WAS EXPLANT

  Patient problems: Asystole; Syncope/Fainting

  MAUDE report 21688021 ↗
• MalfunctionFeb 11, 2025Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT REVIEW WAS REQUESTED OF THE DATA FROM THIS PACEMAKER SYSTEM. TECHNICAL SERVICES (TS) ANALYZED DEVICE EPISODE DATA AND FOUND MANY VENTRICULAR EPISODES DUE TO OVERSENSING OF MYOPOTENTIAL NOISE ON THE RIGHT VENTRICULAR (RV) LEAD CHANNEL FOR THE PAST FOUR YEARS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS PACEMAKER SYSTEM REMAINS IN SERVICE. ACCORDING TO ADDITIONAL INFORMATION, THERE WAS AN ALERT FOR OUT OF RANGE SHOCK LEAD IMPEDANCE VALUES. TECHNICAL SERVICES (TS) NOTED THAT THE VALUES WERE LESS THAN 200 OHMS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS PACEMAKER SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356541 ↗
• InjuryJan 21, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED DUE TO UNKNOWN REASONS AT THIS TIME. NO FURTHER INFORMATION WAS INITIALLY PROVIDED, HOWEVER, IT HAS BEEN REQUESTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE HAS BEEN RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21198945 ↗
• InjuryDec 11, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER DEVICE HAS TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) FOR THREE TIMES. DATA ANALYSIS WAS REQUESTED AND SHOWED THAT THE ERI TRIP POINTS WERE SHIFTED DUE TO CHANGES IN POWER CONSUMPTION. THE BATTERY VOLTAGE WAS BELOW THE EXPECTATION WHICH CAN BE DIFFICULT TO PREDICT THE FUTURE VOLTAGES. IN ADDITION, THIS PATIENT EXPERIENCED INFECTION. AS OF THIS TIME, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 20904793 ↗
• InjuryNov 5, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER WAS SUSPECTED OF PREMATURE BATTERY DEPLETION (PBD). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ASSESSED THAT DEVICE WAS NOT PART ON ADVISORY AND HAS BEEN IMPLANTED FOR MORE THAN 10 YEARS. MOREOVER, REPORT SHOWED THAT THE BATTERY AT 2.5 YEARS REMAINING WITH POWER CONSUMPTION. AS OF THIS TIME, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609998 ↗
• InjuryOct 16, 2024Adverse 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 THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 20461218 ↗
• MalfunctionSep 25, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PRODUCT WAS RETURNED WITH NO REPORTED PRODUCT PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. ANALYSIS COMPLETED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY IDENTIFIED A PRODUCT PERFORMANCE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302986 ↗
• MalfunctionAug 5, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR (RV) LEAD CHANNEL THAT TRIGGERED A RED CALL DOCTOR (RCD) ON THE COMMUNICATOR. THE MEASUREMENT SUDDENLY DROPPED TO WITHIN LIMITS VALUE AND HAS REMAINED STABLE SINCE. THE DEVICE REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19907818 ↗
• InjuryJul 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER WAS EXPLANTED DUE TO UNKNOWN REASONS. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19674378 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER DEVICE CALLED TECHNICAL SERVICES (TS) TO REPORT HAVING EXPERIENCED TWO SYNCOPAL EPISODES. THE PATIENT SPECULATED THAT THE SYNCOPE EPISODES MAY HAVE BEEN DUE TO THE PACEMAKER BATTERY HAVING BEEN DEPLETED. THE PACEMAKER HAD BEEN IMPLANTED FOR ABOUT TEN YEARS AND REACHED END OF LIFE (EOL). IT WAS REPORTED THAT A GENERATOR REPLACEMENT PROCEDURE WAS SCHEDULED. SUBSEQUENTLY, THE DEVICE REPLACEMENT PROCEDURE WAS PERFORMED, AND THE PACEMAKER WAS EXPLANTED AND SUCCESSFULLY REPLACED WITH A NEW DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS RETURNED TO THE FACILITY.

  Patient problems: Syncope/Fainting

  MAUDE report 19556855 ↗
• InjuryJun 7, 2024Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED NOISE, OVERSENSING AND PACING INHIBITION ON THE RIGHT VENTRICULAR (RV) CHANNEL. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED PROGRAMMING AND TROUBLESHOOTING OPTIONS. IT WAS NOTED THAT THIS PATIENT IS PACEMAKER DEPENDENT, BUT DID NOT EXPERIENCE GREATER THAN TWO SECONDS OF ASYSTOLE. FURTHER INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE HAS BEEN RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489006 ↗
• MalfunctionMay 10, 2024Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT A SIGNAL ARTIFACT MONITOR (SAM) EVENT OCCURRED AND MINUTE VENTILATION (MV) WAS TURNED OFF AS A RESULT. EPISODES OF PACEMAKER MEDIATED TACHYCARDIA (PMT) WERE ALSO REPORTED. THE DEVICE AND LEADS REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19283489 ↗
• InjuryMay 7, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER DEVICE HAD STORED SIGNAL ARTIFACT MONITORING (SAM) EPISODES AND EXHIBITED NOISE AND OVERSENSING ON THE RIGHT ATRIAL (RA) CHANNEL. THE MINUTE VENTILATION (MV) FEATURE WAS DISABLED SINCE FEW YEARS NOW. TECHNICAL SERVICES (TS) REVIEWED AND STATED THAT SEVERAL OF THE IMPEDANCE MEASUREMENTS WERE MARKED AS NOISE. THE DAILY TREND SHOWED STABLE RA AND RV IMPEDANCES OVER THE LAST 12 MONTHS. SUBSEQUENTLY THIS DEVICE WAS EXPLANTED, AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19262439 ↗
• InjuryApr 23, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER DEVICE EXHIBITED FAIRFIELD OVERSENSING AND INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR). TECHNICAL SERVICES (TS) REVIEWED THE PRESENTING ELECTROGRAM (EGM) AND STATED THAT THERE WAS INAPPROPRIATE ATR DUE TO FARFIELD OVERSENSING. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164883 ↗