MOMENTUM™ EL ICD DR D121Recalls & reported problems

Summary

The FDA's MAUDE database contains 850 adverse event reports that list this exact device (DI 00802526587726), received between Jan 25, 2018 and Sep 24, 2026 — classified as 2 deaths, 444 injuries, 404 malfunctions.

The most frequently reported specific device problem is “High impedance” (209 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 850 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited high out of range shock impedance measurements for its right ventricular (RV) lead. Technical Services (TS) was consulted and discussed stroed data as well as programming recommendations. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884382 ↗
• MalfunctionSep 24, 2026Low impedance

  It was reported that this implantable cardioverter defibrillator (ICD) system exhibited low out of range pacing impedance measurements on the right atrial (RA) lead. It was noted the device was reprogrammed and the patient would continue to be monitored. No adverse patient effects were reported. This ICD remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883401 ↗
• InjurySep 24, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; High Capture Threshold

  It was reported that this implantable cardioverter defibrillator (ICD) delivered shock therapy for a stable rhythm and exhibited high pacing impedance measurements. The measurements were within range. It was noted the patient would continue to be monitored. No additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50882568 ↗
• MalfunctionSep 17, 2026Over-Sensing

  It was reported that this implantable cardioverter defibrillator (ICD) and right atrial (RA) lead exhibited oversensing that resulted in inappropriate Atrial Tachy Response (ATR) episodes. Technical Services (TS) was consulted and provided troubleshooting options. This ICD and RA lead remain in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797652 ↗
• MalfunctionSep 16, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) system exhibited high out of range right atrial (RA) lead impedance measurements above 3000 Ohms. The patient reported feeling presyncope. Thos ICD had its programming optimized for the patients needs. This ICD system remains in service. No adverse patient effects were reported.

  Patient problems: Presyncope

  MAUDE report 50789671 ↗
• MalfunctionSep 16, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788912 ↗
• MalfunctionSep 15, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50781505 ↗
• InjurySep 14, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50764227 ↗
• MalfunctionSep 10, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) and right ventricular (RV) lead exhibited pacing impedance measurements high out of range, greater than 2000 ohms. Technical Services (TS) reviewed indicated that all other lead measurements were reviewed and were found to be within normal limits. It was also discussed options for troubleshooting. The patient will continue to be monitored. No adverse patient effects were reported. This ICD remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50704162 ↗
• InjurySep 4, 2026Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; Low impedance

  Patient problems: Pericardial Effusion; Shock from Patient Lead(s)

  MAUDE report 50617989 ↗
• MalfunctionSep 4, 2026Under-Sensing

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited right atrial (RA) undersensing. The Boston Scientific Technical Services consultant discussed that the RA sensitivity was set to a non-nominal 0.8 millivolts and suggested to increase sensitivity. 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 50602468 ↗
• MalfunctionSep 4, 2026Over-Sensing; Pacing Problem

  It was reported that the presenting electrogram (EGM) of this implantable cardioverter defibrillator (ICD) showed patient experiencing long/short behavior that lead to true ventricular tachycardia (VT) and therapy delivery. The ICD also exhibited farfield oversensing. The health care professional (HCP) called Technical Services (TS) for programming assistance. TS reviewed the egm and discussed programming optimization recommendations with the HCP. No additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601333 ↗
• MalfunctionSep 4, 2026Over-Sensing

  It was reported that this implantable cardioverter defibrillator (ICD) recorded one non-sustained ventricular tachycardia on intracardiac electrogram with far field R wave over sensing. The report was successfully sent as a transmission. The ICD remains in service at this time. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601119 ↗
• InjuryAug 25, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered potential inappropriate therapy for an atrial arrythmia. Technical Services (TS) reviewed the stored episode and showed atrial fibrillation (AF) with rapid ventricular response (RVR) rhythm that exceeded 200 beats per minute detected in the ventricular fibrillation (VF) zone. anti-tachycardia pacing (ATP) bursts and electric shocks were delivered for the episode. The health care professional (HCP) reported that the patient felt the delivered shock. The device was operating as programmed. No adverse patient effects were reported. This ICD remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50423122 ↗
• InjuryAug 22, 2026Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; Delayed Charge Time; Battery Problem

  It was reported that this implantable cardioverter defibrillator (ICD) had reached Battery Capacity Depleted (BCD) after less than 1.5 years of implant and recorded a Code 1007, indicative of charge time that had exceeded 45 seconds. The patient was at physical therapy the day before, and received multiple shocks. The patient was transported to the emergency department while he was still conscious. The patient then received numerous additional shocks, went into pulseless electrical activity, and was now intubated. The last capacity reform was in (b)(6) 2026 with a charge time (CT) of 10.9 seconds, with 0.56 amp hours remaining. A longevity estimate from (b)(6) 2026 showed approximately 11.5 years remaining, and had not yet taken into account 188 delivered shocks and 85 diverted shocks from (b)(6) 2026. A review of some of those episodes showed true ventricular tachycardia (VT). Technical Services (TS) discussed that the Code 1007 was attributed to the high volume of shocks delivered, requiring significant battery consumption. This ICD remains implanted, however emergent device replacement was recommended. No additional adverse patient effects were reported.

  Patient problems: Cardiac Arrest; Shock from Patient Lead(s)

  MAUDE report 50384377 ↗
• MalfunctionAug 20, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50360098 ↗
• InjuryAug 19, 2026Signal Artifact/Noise; Under-Sensing; Low impedance

  It was reported that this right atrial (RA) lead was successfully explanted due to a low RA lead impedance and noise, with a gradual decrease in RA impedance to below 200 ohms. The RA lead also demonstrated noise and undersensing, with the findings consistent with a suspected insulation issue and myopotential oversensing. No pacing inhibition occurred, as intrinsic activity was present. The RV lead demonstrated high pacing thresholds, greater than 5 V, with variability in impedance over the previous six months but no out-of-range impedance measurement. Technical Services (TS) discussed lead characteristics and sheath sizing considerations with the representative in preparation for the extraction, and the RA and RV leads were addressed as part of the planned procedure. This RA lead was explanted and replaced with another lead. No additional adverse patient effects were reported outside the revision procedure. At this time, this product has not been returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50331321 ↗
• MalfunctionAug 19, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Connection Problem

  It was reported that this implantable cardioverter defibrillator (ICD) and the right ventricular (RV) lead delivered inappropriate anti-tachycardia pacing (ATP) and a single shock due to oversensing of noise. The patient had a strong underlying rhythm, and no pacing inhibition was noted. The field representative (rep) didn't know what the patient was doing when the noise was recorded. Technical Services (TS) discussed troubleshooting options to reproduce the noise and recommended asking what the patient was doing at the time of the shock. This ICD remains in service. No adverse patient effects were reported.Additional information was received from the field. The patient was seen in clinic and the physician suspected subclavian crush. This ICD was explanted and replaced. The RV lead was surgically abandoned and replaced. No additional adverse patient effects were reported.Addinal information was received. This ICD was explanted because the header was not compatible with the new RV lead.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50326261 ↗
• InjuryAug 19, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited noise oversensing on the right ventricular (RV) channel. The patient underwent a surgical intervention to explant this ICD. No new device was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50324074 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable cardioverter defibrillator (ICD) was part of the system revision due to infection. No adverse patient effects were reported. The ICD was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50319155 ↗
• MalfunctionAug 14, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50263489 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) system visited the hospital and reported experiencing a syncopal episode. The device was interrogated and the health care professional (HCP) called Technical Services (TS) for a consult review of the presenting electrogram (EGM). Upon review, the EGM showed device recorded a ventricular episode that correlated with the syncope episode. Further review of the ventricular episode showed that patient was in a ventricular tachycardia (VT) with the ventricular rate greater than atrial rate. The device delivered two shocks and successfully converted the rhythm. No adverse patient effects were reported. This ICD remains in service.

  Patient problems: Syncope/Fainting

  MAUDE report 50245648 ↗
• InjuryAug 12, 2026Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; Interrogation Problem

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited a Code 1006, indicative of a high voltage detected on a lead during a device charge. Technical Services (TS) reviewed the available data and determined that the low-voltage code was valid, with an irregular decrease in battery voltage potentially related to an internal electrical short, noted an alert for Remote Monitoring Disabled (RMD) on radio frequency (RF) telemetry. Subsequently, this ICD was successfully explanted and replaced. No additional adverse patient effects were reported outside the revision procedure. At this time, this product has not been returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225918 ↗
• MalfunctionAug 12, 2026Signal Artifact/Noise; Over-Sensing; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218656 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable cardioverter defibrillator (ICD) was part of a system revision due to Methicillin-resistant Staphylococcus aureus (MRSA) infection. There was no additional adverse patient effects reported. The ICD was explanted.

  Patient problems: Bacterial Infection

  MAUDE report 50209674 ↗

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-0077-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD VR, Model D432, 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-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-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-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-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