DYNAGEN™ CRT-D G154Recalls & reported problems

Summary

The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 00802526534652), received between Oct 13, 2016 and Sep 14, 2026 — classified as 1 death, 94 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (35 reports).

19 other recalls cover devices cleared under the same FDA submission (P010012); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 150 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Over-Sensing

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) recorded episodes of inappropriate Atrial Tachy Responses (ATRs) and far field over sensing. It was recommended to measure the far field signal on programmer and considering the decrease of sensing. Also changing the blanking setting from smart to fixed and extending ATR duration was recommended. There were no impacts to patient. No adverse patient effects were reported. The CRT-D remains in service at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754464 ↗
• InjuryJun 16, 2026Over-Sensing; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) REQUESTED A REVIEW OF AN ARRYTHMIA EPISODE FOR THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). TECHNICAL SERVICES (TS) REVIEWED DEVICE DATA AND OBSERVED ATRIAL CHANNEL OVERSENSING OF VENTRICULAR SIGNALS WITH BIVENTRICULAR (BIV) PACING. AFTER, AN EARLY RIGHT VENTRICULAR (RV) BEAT WAS RECORDED. TS SUSPECTED THAT THIS INDUCED JUNCTIONAL TACHYCARDIA. THE RHYTHM BROKE AFTER APPROXIMATELY FIVE TO SIX SECONDS. TS RECOMMENDED THE HCP REFER TO ELECTROPHYSIOLOGY (EP). THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tachycardia

  MAUDE report 25523829 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PART OF THE S SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE CRT-D WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25025980 ↗
• InjuryNov 18, 2025Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRESENTED TO THE EMERGENCY ROOM DUE TO PAUSES IN PACING GREATER THAN TWO SECONDS AND NUMEROUS INAPPROPRIATE SHOCKS. THE PATIENT HAD SYMPTOMS OF PRESYNCOPE. IT WAS THEN DETERMINED THAT THIS CRT-D WAS IN SAFETY MODE. TECHNICAL SERVICES (TS) RECOMMENDED DEVICE REPLACEMENT. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND REPLACED. AT THIS TIME, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED, AND THIS CRT-D HAS BEEN RETURNED FOR ANALYSIS.

  Patient problems: Asystole; Presyncope; Shock from Patient Lead(s)

  MAUDE report 23582810 ↗
• MalfunctionNov 17, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED OVERSENSING OF THE RIGHT ATRIAL. THE DEVICE RECORDED 3 ATRIAL AND ONVE VENTRICULAR ARRITMIA. NO THERAPY WAS DELIVERED. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576259 ↗
• MalfunctionNov 5, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED VENTRICULAR ARRYTHMIA EPISODES. THE DEVICE DELIVERED APPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND AN ISOLATED SHOCK, WHICH CONVERTED THE RHYTHM. TECHNICAL SERVICES (TS) REVIEWED THE ARRYTHMIA EPISODES AND FOUND OVERSENSING OF NOISY SIGNALS ON THE RIGHT ATRIAL (RA) CHANNEL. TS SUSPECTED THE NOISE WAS DUE TO A MEDICAL PROCEDURE OR ELECTROMAGNETIC INTERFERENCE (EMI). THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476858 ↗
• InjuryOct 31, 2025Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY FOR ELECTROMAGNETIC INTERFERENCE (EMI) DUE TO A MEDICAL PROCEDURE. TECHNICAL SERVICES (TS) STATED THE MAGNET USED WAS LIKELY NOT PLACE CORRECTLY. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23438639 ↗
• MalfunctionOct 15, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT). TECHNICAL SERVICES (TS) WAS CONSULTED AND EXPLAINED THERE WAS CROSS TALK OVERSENSING AND NOISE SIGNALS. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23305199 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED APPROXIMATELY FIVE YEARS AFTER IMPLANT. THIS CRT-D WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083661 ↗
• MalfunctionAug 26, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED AN APPARENT INAPPROPRIATE SHOCK (IAS). TECHNICAL SERVICES (TS) REVIEWED THE EPISODE, WHICH INVOLVED VENTRICULAR FIBRILLATION (VF) DETECTION, ANTI-TACHYCARDIA PACING (ATP) DELIVERY, AND SHOCK THERAPY. THE RHYTHM RE-INITIATED AND MET THE REDETECTION DURATION, PROMPTING THE DEVICE TO BEGIN CHARGING. ALTHOUGH THE RHYTHM SELF-TERMINATED, THE SHOCK WAS COMMITTED DUE TO A PRIOR DIVERT FOLLOWING QUICK CONVERT. TS CONFIRMED THIS BEHAVIOR AS NORMAL DEVICE OPERATION. REDETECTION DURATION IN THE VF ZONE IS NOT PROGRAMMABLE. TS SUGGESTED CONSIDERING AN INCREASE IN THE VF ZONE TO ALLOW ADDITIONAL PROGRAMMING OPTIONS FOR REDETECTION DURATION AND ATP DELIVERY. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22897200 ↗
• MalfunctionAug 7, 2025Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED FAR-FIELD OVERSENSING. IN THE STORED EPISODE, PACING INHIBITION WAS NOTED THAT LASTED APPROXIMATELY 4 SECONDS. TECHNICAL SERVICES (TS) INQUIRED WHETHER A PROCEDURE HAD BEEN PERFORMED ON THE DATE OF THE EVENT AS NOISY SIGNALS WERE NOTED ON THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) CHANNELS AND COULD BE ELECTROMAGNETIC INTERFERENCE (EMI). TS RECOMMENDED TO PERFORM AN ISOMETRICS TEST TO FURTHER EVALUATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: Asystole

  MAUDE report 22742349 ↗
• MalfunctionJun 27, 2025Signal Artifact/Noise; Over-Sensing; Pacing Problem; Low impedance; Signal Artifact/Noise; Over-Sensing; Pacing Problem; Low impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD THE SIGNAL ARTIFACT MONITORING (SAM) SENSOR DISABLE. TECHNICAL SERVICES (TS) WAS CONSULTED AND NOTED NOISE ON THE RIGHT VENTRICULAR (RV) LEAD WHICH CAUSES PACING INHIBITION AND OVERSENSING. RV IMPEDANCE DROPS TWICE AROUND 100OHMS. TS SUSPECTS LEAD FAILURE. LATER ON, THE PATIENT STATE TO HAVE A SKIN PROCEDURE THE SAME DAY OF THE ALLEGATIONS. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 22346626 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRTD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22127531 ↗
• InjuryMay 21, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Delayed Charge Time; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Delayed Charge Time

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED INAPPROPRIATE THERAPY. TECHNICAL SERVICES (TS) WAS CONSULTED, AND IT WAS FOUND THAT MULTIPLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS WERE PROVIDED. THERAPY WAS EXHAUSTED. A DELAY IN ANTI-TACHYCARDIA PACING (ATP) DELIVERY WAS ALSO NOTED. IN ADDITION, REPROGRAMMING OPTIONS FOR PACING OUTPUTS WERE RECOMMENDED, AS THE SAFETY MARGIN WAS NOT MET. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE. ADDITIONAL INFORMATION INDICATED THAT FURTHER REPROGRAMMING OPTIONS WERE PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22058090 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE CRT-D WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21969446 ↗
• InjuryApr 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE CRT-D WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21870257 ↗
• 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. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858724 ↗
• InjuryFeb 13, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK LEAD IMPEDANCES MEASURING ABOVE 200 OHMS. TECHNICAL SERVICES (TS) WAS CONSULTED, AND FURTHER IN OFFICE REVIEW WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376515 ↗
• MalfunctionFeb 12, 2025Over-Sensing; Pacing Problem; Under-Sensing; Over-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT DURING AN ATRIAL TACHY RESPONSE (ATR) EPISODE, THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED INAPPROPRIATE PACING IN THE RIGHT ATRIAL (RA) LEAD CHANNEL, WHICH LED TO BLANKING OF THE INTRINSIC VENTRICULAR ACTIVITY AND INAPPROPRIATE PACING IN THE RIGHT VENTRICULAR (RV) LEAD CHANNEL AS WELL. TECHNICAL SERVICES (TS) WAS CONSULTED, AND PROGRAMMING ENHANCEMENTS WERE DISCUSSED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED, THE HEALTH CARE PROFESSIONAL (HCP) REQUESTED A REVIEW OF THE PRESENTING ELECTROGRAM (EGM) FOR THIS CRT-D. TECHNICAL SERVICES (TS) DISCUSSED THE PRESENTING SHOWED CROSSTALK OVERSENSING OF VENTRICULAR PACING IN THE ATRIAL CHANNEL. TS RECOMMENDED POSSIBLE REPROGRAMMING OPTIONS. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21369248 ↗
• MalfunctionFeb 7, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXHIBITING PACING IMPEDANCE HIGH OUT OF RANGE AND CONTINUES TO RISE. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334313 ↗
• MalfunctionDec 5, 2024High impedance; Over-Sensing; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; High impedance; Over-Sensing; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED A CODE 1005, INDICATIVE OF AN OPEN CIRCUIT CONDITION DETECTED DURING SHOCK DELIVERY DUE TO A HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS. ADDITIONALLY, THIS DEVICE STORED SIGNAL ARTIFACT MONITORING (SAM) EPISODE WHICH REVEALED THE RIGHT VENTRICULAR (RV) LEAD HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. RIGHT ATRIAL (RA) NON PHYSIOLOGIC NOISE WAS OBSERVED WHICH WAS BEING OVERSENSED, RESULTING IN PACING INHIBITION OF GREATER THAN 2 SECONDS. TECHNICAL SERVICES (TS) NOTED THIS PATIENT'S INTRINSIC RHYTHM WAS COMING THROUGH. NEXT, THE PATIENT EXPERIENCED A V-3 EVENT FOLLOWED BY NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT). ALTHOUGH ANTI-TACHYCARDIA PACING (ATP) WAS ATTEMPTED, IT FAILED TO CONVERT THE RHYTHM, AND THE DEVICE SUBSEQUENTLY CHARGED AGAIN. DESPITE THE RHYTHM SELF-TERMINATING, A SHOCK WAS DELIVERED DUE TO THE PREVIOUS CHARGE DIVERT. THE PATIENT EXPERIENCED AN INAPPROPRIATE SHOCK (IAS) AS A RESULT. THIS SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole; Shock from Patient Lead(s)

  MAUDE report 20856428 ↗
• MalfunctionDec 5, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS OVERSENSING ATRIAL EVENTS ON THE VENTRICULAR CHANNEL. TECHNICAL SERVICES (TS) NOTED THAT THE SIGNAL APPEARED TO COME IN BEFORE ANY CROSS CHAMBER BLANKING AND RECOMMENDED PROGRAMMING CHANGES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20856050 ↗
• InjuryNov 20, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Inaccurate Synchronization; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Inaccurate Synchronization

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED INAPPROPRIATE SHOCKS AND ANTI-TACHYCARDIA PACING (ATP) DUE TO SUPRAVENTRICULAR TACHYCARDIA (SVT). ADDITIONALLY, ONE ATP REPORTEDLY ACCELERATED THE RATE OF THE PATIENT'S ARRHYTHMIA INTO VENTRICULAR FIBRILLATION (VF). A SHOCK SUCCESSFULLY CONVERTED THE VF. THE CRT-D SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s); Ventricular Fibrillation

  MAUDE report 20740843 ↗
• InjuryOct 18, 2024Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED EPISODES OF INAPPROPRIATE SHOCKS DUE TO NOISE AND OVERSENSING. NO OTHER INFORMATION WAS PROVIDED. THIS DEVICE WAS A YEAR AFTER IMPLANT. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20487885 ↗
• MalfunctionOct 10, 2024Under-Sensing; Low impedance; Under-Sensing; Low impedance

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) AND REQUESTED A REVIEW OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRESENTING ELECTROGRAM (EGM). UPON REVIEW, THE PRESENTING EGM SHOWED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW OUT OF RANGE PACING IMPEDANCES AND UNDERSENSING. IT WAS NOTED THAT THE RA LEAD IS A NON-BOSTON SCIENTIFIC LEAD. TS DISCUSSED WITH THE HCP POSSIBLE CAUSES AND RECOMMENDED TROUBLESHOOTING OPTIONS. AT THIS TIME, THE CRT-D AND NON-BOSTON SCIENTIFIC RA LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20418530 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010012. One submission often covers many models, so check the product and lot details in each record.

• Z-1671-2022 · 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-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-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, Sterile.
• Z-0081-2018 · Oct 4, 2017 · Terminated
  RESONATE X4 CRT-D, Model G447, Sterile.
• Z-1556-2010 · Mar 15, 2010 · Terminated
  Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H220, H225, H227, H229. The LIVIAN family of cardiac resynchronization therapy defibrillat
• Z-0609-2010 · Dec 1, 2009 · Terminated
  Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107,
• Z-1055-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are design
• Z-1052-2007 · Mar 23, 2007 · Terminated
  VITALITY AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. P
• Z-1053-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 (model T165, T175), VITALITY DS (model T125, T135), VITALITY EL (model T127), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventric
• Z-1047-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 (model H170, H175) CONTAK RENEWAL 3 HE (model H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North,
• Z-1054-2007 · Mar 23, 2007 · Terminated
  VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 U
• Z-1049-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 RF (model H210, H215), CONTAK RENEWAL 3 RF HE (model H217, H219) cardiac resynchronization therapy defibrillator (CRT-D).
• Z-0047-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY VR/DR, Implantable Cardioverter Defibrillator, ICD, Models 1870 and 1871. Guidant VITALITY DR+, Implantable Cardioverter Defibrillator, ICD, Model 1872.
• Z-1288-06 · May 15, 2006 · Terminated
  Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Ave
• Z-0825-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 3 (models H170,H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100

…and 4 more.