DYNAGEN™ MINI ICD DR D023Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 00802526533921), received between Apr 25, 2016 and Apr 23, 2026 — classified as 43 injuries, 34 malfunctions.

The most frequently reported specific device problem is “High impedance” (34 reports).

14 other recalls cover devices cleared under the same FDA submission (P960040); they may or may not involve this specific model.

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 77 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Battery Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED ELECTIVE REPLACEMENT INDICATOR STATE RESULTING TO DEVICE DATA UPLOAD ANOMALY. THE BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED THAT THE DEVICE BATTERY COULD GO TO END OF LIFE BATTERY STATE AT ANY TIME AND DEVICE REPLACEMENT WAS RECOMMENDED. SUBSEQUENTLY, TACHY THERAPY WAS PROGRAMMED OFF. THE TS CONSULTANT DISCUSSED THAT IF THE PACING MODE IS CURRENTLY DEACTIVATED, THIS THERAPY CANNOT BE REACTIVATED AFTER THE BATTERY CAPACITY IS DEPLETED, THOUGH THIS MAY BE TURNED OFF LATER IF THIS REMAINS IN A SENSING-ONLY MODE. AS OF THIS TIME, THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968282 ↗
• MalfunctionNov 5, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INTERMITTENT HIGH OUT OF RANGE RIGHT VENTRICULAR (RV) LEAD IMPEDANCES ABOVE 3000 OHMS FOR THE LAST YEAR. THERE WAS NO NOISE OBSERVED. TECHNICAL SERVICES (TS) WAS CONSULTED TO CHECK IF IT WAS POSSIBLE TO PERFORM A MAGNETIC RESONANCE IMAGING (MRI); HOWEVER, FURTHER GUIDANCE WAS PROVIDED TO CONSULT WITH THE PHYSICIAN. THIS DEVICE REMAINS IN-SERVICE AT THIS TIME. NO ADVERSE PATIENT EVENTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT FURTHER EVALUATION HAD BEEN CONDUCTED. HIGH OUT OF RANGE PACING IMPEDANCES WITH VALUES GREATER THAN 3000OHMS TO 800OHMS WERE NOTED IN THE STORED DATA; HOWEVER, IMPEDANCES WERE NOTED TO BE STABLE DURING IN CLINIC EVALUATION ALONG WITH THRESHOLDS AND SENSING. FURTHERMORE, NO NOISE WAS REPRODUCED. THIS DEVICE REMAINS IN-SERVICE AT THIS TIME. NO ADVERSE PATIENT EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479028 ↗
• MalfunctionSep 9, 2025Over-Sensing; Failure to Read Input Signal; Over-Sensing; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED CROSSTALK OVERSENSING OF ATRIAL SIGNALS ON THE RIGHT VENTRICULAR (RV) CHANNEL. RV AUTOMATIC GAIN CONTROL (AGC) WAS PROGRAMMED TO 0.9 MV. UPON INCREASING RV SENSITIVITY TO 1 MV, ELECTROGRAMS (EGMS) WERE MONITORED FOR A FEW MINUTES AND NO CROSSTALK WAS OBSERVED. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS, AND RECOMMENDED DEFIBRILLATION THRESHOLD (DFT) TESTING. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012431 ↗
• InjurySep 2, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD LONGEVITY DROPPED FROM 10 MONTHS TO ELECTIVE REPLACEMENT INDICATOR (ERI). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT EXPLANT WAS DECLARED DUE TO CHARGE TIME OR MORE THAN 15 SECONDS. FURTHER THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935788 ↗
• MalfunctionApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. NO OTHER INFORMATION WAS PROVIDED. THIS DEVICE WAS EXPLANTED AT A LATER TIME FOR AN UNRELATED REASON. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860390 ↗
• MalfunctionFeb 11, 2025Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A BATTERY CAPACITY DEPLETED BEHAVIOR FASTER AS EXPECTED. TECHNICAL SERVICES (TS) WAS CONSULTED, AND IT WAS EXPLAINED THAT THE DEPLETION COULD BE RELATED TO THE AMOUNT OF THERAPY PROVIDED, HOWEVER IT WAS NOT CONCLUSIVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355245 ↗
• InjuryFeb 3, 2025Pacing Problem; Inaccurate Synchronization; Under-Sensing; Pacing Problem; Inaccurate Synchronization; Under-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STORED TWO EPISODES THAT WERE ANALYZED. THE FIRST EPISODE SHOWED A NON-SUSTAINED VENTRICULAR TACHYCARDIA WHERE AN ATRIAL PACE BLANKED THE VENTRICULAR INTRINSIC DEFLECTION. THIS OCCURRED DUE TO A DEVICE ALGORITHM THAT CAUSED PREMATURE ATRIAL PACING, THEN THE DEVICE PACED IN THE VENTRICLE, AND THIS APPEARED TO HAVE INDUCED A VENTRICULAR ARRHYTHMIA. AT THE END OF THE EPISODE THE RATE FELL BELOW THE THERAPY ZONE. SOME MINUTES LATER A NEW VENTRICULAR EPISODE STARTED WHERE APPROPRIATE ANTI-TACHYCARDIA PACING, AND SHOCKS WERE DELIVERED. REPROGRAMMING SUGGESTIONS WERE DISCUSSED WITH THE CALLER. THE ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia

  MAUDE report 21292805 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THE PATIENT CAME INTO THE HOSPITAL WITH THE LEADS ERODED THROUGH THE SKIN. A POCKET REVISION WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 20467246 ↗
• MalfunctionAug 14, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING AN ALERT FOR SHOCK LEAD IMPEDANCE GREATER THAN125OHM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981436 ↗
• MalfunctionAug 13, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STATED THAT THEIR REMOTE COMMUNICATOR DISPLAYED A RED CALL DOCTOR ICON. A LATITUDE NXT REPORT SUGGESTS THE ALERT IS DUE TO SHOCK IMPEDANCE OUT OF RANGE MEASUREMENTS. SUBSEQUENTLY, TECHNICAL SERVICES (TS) WAS CONSULTED AND GUIDED TROUBLESHOOTING OPTIONS, BUT AN UPLOAD WAS UNSUCCESSFUL. TS ADVISED PATIENT TO CONTACT THEIR CLINIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977470 ↗
• MalfunctionDec 20, 2023High impedance; Defective Device; High impedance; Defective Device

  IT WAS REPORTED THAT THE COMMUNICATOR FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SHOWING A RED CALL DOCTOR ICON, THREE YELLOW COLLECTING WAVES, TWO YELLOW SENDING WAVES AND WAS NOT ABLE TO CONNECT. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE HAD REFERRED THE PATIENT TO THE CLINIC. THE COMMUNICATOR ISSUE WAS NOT RESOLVED. A NEW CELLULAR ADAPTER WAS SENT. THE COMMUNICATOR REMAINS IN SERVICE AND THE ICD HAS BEEN EXPLANTED DUE TO NORMAL BATTERY DEPLETION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE MENTIONING THAT THERE WAS A YELLOW ALERT DUE TO HIGH, OUT-OF-RANGE RIGHT ATRIAL (RA) LEAD PACING IMPEDANCES. BOTH RA AND ICD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18362197 ↗
• InjuryDec 11, 2023Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Data Problem; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Data Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAS REACHED EXPLANT INDICATOR. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT HAS AN INFECTION HOWEVER, THE HEALTH CARE PROFESSIONAL (HCP) DOES NOT THINK IT IS RELATED TO THE DEVICE. IT WAS NOTED THAT THE PATIENT RECEIVED SHOCK THERAPY HOWEVER, THE TOTAL NUMBER OF SHOCKS WERE UNKNOWN, AND THE CAUSE IS UNKNOWN SINCE THE REVIEW OF EPISODES ARE NOT AN OPTION. THE HCP WAS INQUIRING ABOUT DEVICE SETTINGS. TECHNICAL SERVICES DISCUSSED HOW TACHY THERAPY ZONE WAS AT 165 AND WHEREAS BEFORE TACHY THERAPY DID NOT START UNTIL 200. THERE WERE SEVERAL STORED EPISODES IN WHICH THE TACHY ZONE WAS BETWEEN 150-200. AT THIS TIME, THE DEVICE AND NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SUPPLEMENTAL REPORT IS BEING FILED AS ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock; Unspecified Infection

  MAUDE report 18300530 ↗
• MalfunctionOct 27, 2023Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE RECEIVED ONE APPROPRIATE SHOCK AFTER 40 SECONDS OF VENTRICULAR TACHYCARDIA (VT). THE PATIENT HAD A SYNCOPAL EPISODE. THE PLAN IS TO CONTINUE MONITORING AND OPTIONS FOR FASTER THERAPY DELIVERY WERE DISCUSSED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 18021756 ↗
• InjuryOct 17, 2023Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NOISE ON BOTH THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD. AS A RESULT, THE DEVICE DELIVERED INAPPROPRIATE ELECTRIC SHOCKS. THE PATIENT WAS EVALUATED IN THE EMERGENCY ROOM AND REPROGRAMMING WAS PERFORMED AND THE TACHY MODE OF THE DEVICE WAS DEACTIVATED. A REVISION PROCEDURE WAS PERFORMED AND BOTH THE RA AND RV LEADS WERE SURGICALLY ABANDONED. THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 17950201 ↗
• MalfunctionAug 22, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXHIBITING INTERMITTENT RIGHT ATRIAL (RA) LEAD CHANNEL UNDERSENSING, THE ISSUE WAS RESOLVED WITH REPROGRAMMING. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597006 ↗
• InjuryJul 26, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STATED THAT THEIR REMOTE COMMUNICATOR DISPLAYED A RED CALL DOCTOR ICON. SUBSEQUENTLY, TROUBLESHOOTING WAS PERFORMED, AND THE COMMUNICATOR WAS POWER CYCLED, HOWEVER THE ISSUE HAS NOT BEEN RESOLVED. THE PATIENT WAS REFERRED TO CONTACT THEIR CLINIC REGARDING THE RED CALL DOCTOR ICON. AT THIS TIME, THIS DEVICE REMAINS IN SERVICE AND THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17402292 ↗
• MalfunctionApr 6, 2023Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED FOR REVIEW OF DEVICE DATA. TECHNICAL SERVICES REVIEWED THE DEVICE DATA AND FOUND THERE WERE INTERMITTENT PACING SPIKES ON THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD HOWEVER, MEASUREMENTS WERE NOTED TO BE WITHIN RANGE. THERE WERE NO OBSERVATIONS OF NOISE. ADDITIONALLY, THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD EXHIBITED MYOPOTENTIAL NOISE THAT WAS BEING OVERSENSED RESULTING IN INAPPROPRIATE STORED ATRIAL TACHY RESPONSE (ATR) EPISODES. RA PACING IMPEDANCES WERE NOTED TO BE STABLE. TECHNICAL SERVICES DISCUSSED POSSIBLE CAUSES AND PROVIDED TROUBLESHOOTING OPTIONS. AT THIS TIME, THIS SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691239 ↗
• MalfunctionMar 22, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED SHOCK OUT-OF-RANGE IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICE (TS) WAS REACHED OUT AND TROUBLESHOOTING OPTIONS WERE RECOMMENDED. AT THIS TIME THE PRODUCT REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16595788 ↗
• MalfunctionFeb 22, 2023High impedance; Defective Device; High impedance; Defective Device

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ATTEMPTED TO BE IMPLANTED DUE TO HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THIS DEVICE WAS NEVER IN SERVICE, AND A NEW DEVICE WAS PLACED. THIS DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16421125 ↗
• InjuryJan 17, 2023High impedance; Over-Sensing; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED FOR REVIEW OF DEVICE DATA FOR THIS PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE HCP SUSPECTS THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD IS FRACTURED. TECHNICAL SERVICES REVIEWED THE DEVICE DATA AND FOUND RA IMPEDANCES HAVE BEEN VARIABLE TO HIGH OUT-OF-RANGE. MEASURING GREATER THAN 3,000 OHMS. ADDITIONALLY, THERE WAS OBSERVATIONS OF NOISE THAT WAS BEING OVERSENSED BY THE RESPIRATORY RATE TREND (RRT) SENSOR. TECHNICAL SERVICES DISCUSSED POSSIBLE CAUSES AND RECOMMENDED TO INTERROGATE USING THE PROGRAMMER. AT THIS TIME, THE ICD SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SUPPLEMENTAL REPORT IS BEING FILED AS ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THIS PACEMAKER WAS EXPLANTED AND REPLACED SUCCESSFULLY. THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16185588 ↗
• InjuryJan 16, 2023Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM, IMPLANTED WITH ANOTHER MANUFACTURER'S RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS, UNDERWENT A SYSTEM REVISION. HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS >3,000 OHMS WERE FIRST DETECTED ON THE RA CHANNEL (B)(6) 2020, AND THE RA LEAD WAS TURNED OFF. HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS >3,000 OHMS WERE LATER DETECTED ON THE RV CHANNEL AS EARLY AS (B)(6) 2022. NO NOISE EVENTS WERE STORED SINCE THE IMPEDANCES WENT OUT OF RANGE, HOWEVER (V-1) A STORED EPISODE BACK FROM (B)(6) 2019 HAD SHOWED SOME POSSIBLE EMI NOISE WITH OVERSENSING. THE PHYSICIAN SUSPECTED CLAVICULAR CRUSH, BUT IT WAS UNCLEAR WHETHER THIS WAS FOR ONE OF BOTH LEADS. HOWEVER, TECHNICAL SERVICES (TS) DISCUSSED POSSIBLE SPRING CONTACT BEHAVIOR DUE TO LACK OF RECENTLY STORED NOISE EVENTS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ICD WAS EXPLANTED/REPLACED WITH SINGLE CHAMBER ICD, THE LEADS WERE SURGICALLY ABANDONED DUE TO LEAD DISLODGEMENT, AND THE RV LEAD WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16174813 ↗
• MalfunctionDec 15, 2022Over-Sensing; Impedance Problem; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE EXHIBITED A STORED SIGNAL ARTIFACT MONITOR (SAM) EPISODE DUE TO OVERSENSING SIGNALS ON THE RIGHT ATRIAL (RA) LEAD. AS A RESULT, THE RESPIRATORY RATE TREND (RRT) SENSORS MONITORING VECTOR WAS AUTOMATICALLY SWITCHED TO THE RIGHT VENTRICULAR (RV) LEAD. IN ADDITION, THE RA LEAD IS EXHIBITING INTERMITTENT SUDDEN INCREASES IN PACE IMPEDANCE MEASUREMENTS, WITH MEASUREMENTS AS HIGH AS 1306 OHMS, WHICH IS STILL WITHIN NORMAL SPECIFICATION LIMITS. THE RA LEAD IS NOT A BOSTON SCIENTIFIC PRODUCT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED WITH THE HEALTHCARE PROVIDER (HCP) THE RRT SENSOR, TRANSTHORACIC IMPEDANCE SIGNALS AND RRT OVERSENSING. TS INDICATED RRT OVERSENSING CAN SOMETIMES DEVELOP WITH SYSTEMS CONTAINING A DEVICE AND LEADS FROM DIFFERENT MANUFACTURERS. TS EXPLAINED THAT THE RRT MONITORING VECTOR HAS SWITCHED AND NOTED RRT OVERSENSING SHOULD NOT BE A PROBLEM WITH THE RV LEAD, AS IT IS ALSO A BOSTON SCIENTIFIC PRODUCT. TS NOTED THAT THEY REVIEWED THE MOST RECENT ATRIAL TACHY RESPONSE (ATR) EPISODES, AND THEY WERE FREE OF NOISE. TS PROVIDED GUIDANCE TO CONSIDER MONITORING FOR NOW. TS ALSO STATED THAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15988081 ↗
• InjuryNov 14, 2022Signal Artifact/Noise; Impedance Problem; Signal Artifact/Noise; Impedance Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED NOISE AS WELL AS OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. TACHY THERAPY WAS PROGRAMMED OFF FOR THIS LEAD. TECHNICAL SERVICES (TS) ANALYZED DEVICE EPISODE DATA AND DETERMINED THAT THE NOISE WAS NON-PHYSIOLOGICAL. ACCORDING TO ADDITIONAL INFORMATION RECEIVED, IT WAS DETERMINED THAT THE NOISE AND PACING IMPEDANCE MEASUREMENTS WERE DUE TO THE RIGHT VENTRICULAR (RV) LEAD WHICH HAD BECOME DISLODGED. IT WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15791449 ↗
• MalfunctionNov 4, 2022Signal Artifact/Noise; Pacing Problem; Impedance Problem; Signal Artifact/Noise; Pacing Problem; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS CHECKED ON THE EMERGENCY ROOM (ER) DUE TO FEELING FATIGUED. UPON REVIEWED, IT WAS FOUND THAT THE DEVICE EXHIBITED PACING INHIBITION WITH ASYSTOLE OF MORE THAN TWO SECONDS, DUE TO NOISY SIGNALS ON THE NON BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD. SUBSEQUENTLY THE DEVICE WAS TURNED OFF. THE FIELD REPRESENTATIVE REQUESTED CONFIRMATION FROM TECHNICAL SERVICES (TS) TO TURN ON THE DEVICE. TECHNICAL SERVICES (TS) REVIEWED THE EPISODES AND FOUND OUT THE RV LEAD ALSO EXHIBITED HIGH IMPEDANCES OUT OF RANGE. TS DID NOT RECOMMEND TURNING THE ICD ON AS THIS COULD PUT THE PATIENT AT RISK FOR INAPPROPRIATE THERAPY AND MORE INHIBITION OF PACING FROM NOISE. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole; Fatigue

  MAUDE report 15725728 ↗
• MalfunctionOct 7, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED A GRADUAL RISE IN RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCES MEASURING 1014-1302 OHMS. AT THE LAST OFFICE VISIT PACING IMPEDANCES MEASURED 1500 OHMS. TECHNICAL SERVICES DISCUSSED THE NORMAL RANGE IS 300-1200 OHMS. THE PLAN IS TO BRING THE PATIENT IN AND TROUBLESHOOT THE LEAD. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15567359 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P960040. One submission often covers many models, so check the product and lot details in each record.

• Z-1670-2022 · Jul 7, 2022 · Open, Classified
  The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all
• Z-0078-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD DR, Model D433, Sterile.
• Z-0079-2018 · Oct 4, 2017 · Terminated
  VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharma
• Z-0077-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD VR, Model D432, Sterile.
• Z-1555-2010 · Mar 15, 2010 · Terminated
  Boston Scientific CONFIENT, model E030, Implantable Cardioverter Defibrillator (ICD). The CONFIENT Implantable Cardioverter Defibrillator (ICDs) are designed to detect and termina
• Z-0610-2010 · Dec 1, 2009 · Terminated
  Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethyle
• Z-1621-2009 · Mar 4, 2009 · Terminated
  GUIDANT VITALITY DS VR Model T135 VR; EL Model T127 DR; 2ICD Model T165 DR; 2ICD Model T175 VR; 2EL ICD Model T167 DR; 2 EL ICD Model T177 VR; DS Model T125 DR. Implantable Cardi
• Z-1513-2008 · Jan 7, 2008 · Terminated
  VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872
• Z-1514-2008 · Jan 7, 2008 · Terminated
  VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber
• Z-0050-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY DS DR/VR (Models T125, T135), Guidant VITALITY EL (Model T127), Guidant VITALITY DR HE (Model T180), Implantable Cardioverter Defibrillators (ICD). Guidant Corpor
• Z-0051-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY 2 DR/VR (Models T165, T175) and Guidant VITALITY 2 EL DR/VR (Models T167, T177). Implantable Cardioverter Defibrillator, ICD. Guidant Corporation, 4100 Hamline A
• Z-1297-06 · Jun 24, 2006 · Terminated
  Guidant VENTAK PRIZM VR (model 1860) and VENTAK PRIZM DR (model 1861) Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide.
• Z-1292-06 · May 15, 2006 · Terminated
  Guidant VITALITY 2 (models T165, T175), VITALITY DS (model T125), VITALITY EL (model T135), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ven
• Z-0828-06 · Apr 7, 2006 · Terminated
  Guidant VITALITY HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 551