NA 6996SQ41 (UDI 00643169541184)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00643169541184), received between Aug 10, 2018 and Jun 6, 2025 — classified as 16 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (13 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. 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2025Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT DURING THE EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (EV-ICD) SYSTEM IMPLANT DEFIBRILLATION THRESHOLD TESTING (DFT) WAS PERFORMED AND UPON THE FIRST ATTEMPT HIGH DFT THRESHOLDS WERE OBSERVED AND WERE UNABLE TO SUCCESSFULLY CONVERT THE PATIENT AT 40 JOULES (J). THE PROCEDURE WAS COMPLETED. UPON THE SECOND ATTEMPT AT DFTS THE FOLLOWING DAY WITH THE ADDITION OF THE SUBCUTANEOUS LEAD, THE DEVICE WAS UNABLE TO DELIVER ENERGY FOR DEFIBRILLATION, 0J DELIVERED WITH AN IMPEDANCE VALUE OF LESS THAN 30 OHMS. THE EV ICD SYSTEM WAS EXPLANTED THE SUBCUTANEOUS LEAD WAS ATTEMPTED BUT NOT USED AND THE PATIENT WAS IMPLANTED WITH A TRANSVENOUS SYSTEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161382 ↗
• InjuryAug 20, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT DURING USE OF THE RIGHT VENTRICULAR (RV) LEAD, AN LEAD ALERT TRIGGERED FOR HIGH SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE.   AN INCREASE IN RV COIL IMPEDANCE WAS ALSO NOTED.  THE RV LEAD WAS EXPLANTED AND REPLACED.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20008803 ↗
• InjuryAug 5, 2024Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) DEFIBRILLATION SUBCUTANEOUS LEAD EXHIBITED HIGH OUT OF RANGE (OOR), SPIKE, AND RISING IMPEDANCES. THE HIGH VOLTAGE LEAD WAS SUSPECTED TO BE FRACTURED. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906108 ↗
• MalfunctionApr 2, 2024Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOW DEFIBRILLATION IMPEDANCE. THE RV LEAD WAS IMPLANTED ON THE POSTERIOR LV. THE RIGHT ATRIAL (RA) LEAD EXHIBITED CHRONIC HIGH THRESHOLDS. THE RV AND RA LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021458 ↗
• InjuryMar 1, 2024Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THAT THE RIGHT VENTRICULAR (RV) LEAD TIP TO COIL IMPEDANCE WAS VARIABLE AND INCREASED TO HIGH UNDEFINED MEASUREMENTS. IN ADDITION, THE DEFIBRILLATION IMPEDANCE WAS VARIABLE AND RISING AND ALSO SPIKED TO HIGH UNDEFINED MEASUREMENTS. THE LEAD HAD A SUSPECTED DEFIBRILLATION COIL FRACTURE, AND THE LEAD IMPEDANCE ALERT TONES WERE PROGRAMMED OFF. BOTH THE RV PACE/SENSE LEAD AND RV DEFIBRILLATION LEAD WERE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18815926 ↗
• MalfunctionFeb 7, 2024Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION LEAD EXHIBITED RISING SVC DEFIBRILLATION IMPEDANCE WHICH BECAME HIGH AND TRIGGERED AN ALERT, AND REVIEW OF AN INTERROGATION SHOWED THAT THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD ALSO TRIGGERED AND ALERT FOR OUT OF RANGE (OOR) RV DEFIBRILLATION IMPEDANCE. THE SVC DEFIBRILLATION LEAD WAS EXPLANTED AND REPLACED, AND THE RV DEFIBRILLATION LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660750 ↗
• MalfunctionOct 26, 2023Impedance Problem; Impedance Problem

  IT WAS FURTHER REPORTED THAT DURING A FOLLOW-UP DEVICE CHECK POST-IMPLANT, IMPEDANCES HAD RISEN BACK TO NORMAL RANGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011368 ↗
• InjuryJul 26, 2023Failure to Convert Rhythm; Device Dislodged or Dislocated; Failure to Convert Rhythm; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST IMPLANT, AN X-RAY SHOWED THE RIGHT VENTRICULAR (RV) LEAD WAS PULLED BACK/DISLODGED. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED AND HAD FAILED. THE RV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397256 ↗
• MalfunctionJul 13, 2023Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR OUT OF RANGE (OOR) LOW DEFIBRILLATION IMPEDANCE. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317474 ↗
• InjuryMay 10, 2023Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH DEFIBRILLATION IMPEDANCE. IN ADDITION, THERE WAS ALSO A SPIKE IN RV COIL AND SUPERIOR VENA CAVA (SVC) SUBCUTANEOUS LEAD IMPEDANCES. IT WAS ALSO NOTED THAT THE PATIENT IS IN HOSPICE. THE ALERTS FOR THE RV LEAD AND SVC LEAD WERE PROGRAMMED OFF, ALONG WITH THERAPIES. THE LEADS REMAIN IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16906128 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16461829 ↗
• InjuryFeb 6, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH/UNDEFINED DEFIBRILLATION IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16304913 ↗
• InjuryJan 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A FRACTURED COIL. IT WAS ALSO FOUND THAT THE PATIENT HAD A HEMATOMA. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 16224295 ↗
• InjuryNov 18, 2022High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH DEFIBRILLATION IMPEDANCE. IN ADDITION, THERE WAS ALSO SPIKE IN RV COIL AND SUPERIOR VENA CAVA (SVC) COIL IMPEDANCES. IT WAS ALSO NOTED THAT THE PATIENT IS IN HOSPICE. THE ALERTS FOR THE RIGHT VENTRICULAR (RV) LEAD AND THERAPIES WERE PROGRAMMED OFF. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15826436 ↗
• MalfunctionOct 27, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THE EPICARDIAL PACE/SENSE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NON-PHYSIOLOGIC SIGNALS APPEARING TO BE VERTICAL LINES ON RECORDED EPISODES. INTERROGATION SHOWED THAT THE PACE/SENSE RV LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC), AND AN ALERT FOR LEAD NOISE WAS ALSO TRIGGERED FOR OVERSENSING OF NOISEEPISODES. THE PATIENT RECEIVED A SHOCK AROUND THE TIME OF THE ALERTS, AND THE PATIENT HAD BEEN EXERCISING WHEN THEY RECEIVED THE SHOCK. IT WAS SUSPECTED THAT THE SHOCK WAS INAPPROPRIATE DUE TO THE OBSERVED OVERSENSING. IT WAS ADDITIONALLY REPORTED THAT LESS THAN THE PROGRAMMED HIGH VOLTAGE ENERGY WAS DELIVERED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND DEFIBRILLATION RV LEAD FOR THE SHOCK INDICATING THAT SHORT CIRCUIT PROTECTION WAS TRIGGERED DURING HIGH VOLTAGE THERAPY, HOWEVER THE ARRHYTHMIA WAS TERMINATED AFTER THERAPY. HOSPITALIZATION WAS REQUIRED, AND THE ICD AND BOTH RV LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679390 ↗
• InjuryJul 1, 2022Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE SUPERIOR VENA CAVA (SVC) SUBCUTANEOUS LEAD HAD AN INCREASE IN SVC IMPEDANCE AND A LEAD FRACTURE WAS SUSPECTED. IN ADDITION, CHANGES WERE SEEN IN THE RIGHT VENTRICULAR (RV) COIL IMPEDANCE VALUES THAT CORRELATED WITH THE SVC IMPEDANCE INCREASES. THE SVC SUBCUTANEOUS LEAD WAS EXPLANTED AND REPLACED. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14884275 ↗
• MalfunctionApr 13, 2022Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE (OOR) LOW PACING AND DEFIBRILLATION IMPEDANCES. THE LEAD REMAINS IN USE, AND THE CLINICIAN WILL CONTINUE TO MONITOR THE LEAD AT THIS TIME. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102729 ↗
• MalfunctionMar 9, 2022High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO AUDIBLE ALERTS TRIGGERED BY THEIR RIGHT VENTRICULAR (RV) LEADS. INTERROGATION SHOWED THAT THE EPICARDIAL RV LEAD EXHIBITED HIGH UNDEFINED OUT OF RANGE (OOR) RV DEFIBRILLATION IMPEDANCE, AND THE ENDOCARDIAL RV LEAD EXHIBITED HIGH UNDEFINED OOR SUPERIOR VENA CAVA (SVC) DEFIBRILLATION IMPEDANCE. THE PATIENT WAS ADMITTED FOR "BEING DRY" AND WAS ADMINISTERED FLUIDS. IT WAS NOTED THAT "IMPEDANCES CAME BACK DOWN OVERNIGHT" AFTER THE PATIENT RECEIVED FLUIDS. BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13714119 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVE, AND THE PATIENT TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12923562 ↗
• InjurySep 10, 2021Low impedance; Device-Device Incompatibility; Device Dislodged or Dislocated; Impedance Problem; Low impedance; Device-Device Incompatibility; Device Dislodged or Dislocated; Impedance Problem

  IT WAS FURTHER REPORTED FROM INFORMATION OBTAINED FROM FOLLOW-UP THAT BOTH LEADS HAD LOW IMPEDANCES BECAUSE THEY WERE TOUCHING. IT WAS ALSO CLARIFIED THAT THE IMPEDANCES WERE SLOWLY DROPPING AGAIN DUE TO BUILD UP OF BLOOD IN THE POCKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12455212 ↗
• InjuryMay 27, 2021High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THERE WAS AN ALERT ON BOTH THE RIGHT VENTRICULAR (RV) PACING LEAD AND RV DEFIBRATION LEAD FOR HIGH/UNDEFINED IMPEDANCE SPIKE. A FEW DAYS LATER THERE WAS ANOTHER ALERT FOR HIGH/UNDEFINED IMPEDANCE ON BOT THE PACING AN DEFIBRILLATION RV LEADS. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11894054 ↗
• MalfunctionFeb 23, 2021Low impedance; Impedance Problem; Low impedance; Impedance Problem

  IT WAS REPORTED THAT THE PACING IMPEDANCE ON THE EPICARDIAL LEAD INCREASED SHORTLY AFTER IMPLANT. IT WAS ALSO NOTED THAT THE DEFIBRI LLATION IMPEDANCE WAS DECREASING AND WAS NOTED TO HAVE BECOME LOW. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11365370 ↗
• MalfunctionMay 29, 2020Low impedance; Impedance Problem; Low impedance; Impedance Problem

  IT WAS REPORTED THAT IMPEDANCE ON THE SUBCUTANEOUS DEFIBRILLATION COIL HAD DECREASED AND TRIGGERED AN ALERT FOR LOW IMPEDANCE APPROXIMATELY ONE WEEK POST-IMPLANT. THE LEAD WAS NOTED TO BE IN A HALO POSITION AROUND THE HEART. THE AUDIBLE ALERT WAS DISABLED SO THE PATIENT WOULD NOT HEAR FURTHER ALERTS. PACING IMPEDANCE ON THE RIGHT ATRIAL (RA) LEAD WAS ALSO NOTED TO HAVE DROPPED SIGNIFICANTLY. NO CORRECTIVE ACTION WAS TAKEN ON THE RA LEAD AND THE PATIENT WILL BE MONITORED REMOTELY. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10101167 ↗
• MalfunctionApr 24, 2020High impedance; High impedance

  IT WAS REPORTED THAT THE LEAD WARNING TRIGGERED, AND THE SUBCUTANEOUS SUPERIOR VENA CAVA (SVC) COIL EXHIBITED HIGH/UNDEFINED IMPEDANCES. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9995765 ↗
• MalfunctionMar 4, 2020Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THERE WAS A POSSIBLE VENTRICULAR UNDERSENSED BEAT ON A STORED FAST VENTRICULAR TACHYCARDIA (VT) EPISODE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9785914 ↗