NA 6996SQ41 (UDI 00613994568014)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00613994568014), received between May 9, 2017 and Nov 14, 2025 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “High impedance” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025High impedance; High impedance

  IT WAS REPORTED THAT THERE WAS AN ALERT FOR OUT OF RANGE (OOR) HIGH RIGHT VENTRICULAR (RV) LEAD DEFIBRILLATION IMPEDANCE AND A PREVIOUS WARNING FOR LOW RV LEAD PACING IMPEDANCE. THE SUBCUTANEOUS RV DEFIBRILLATION AND EPICARDIAL RV PACING 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 23558069 ↗
• MalfunctionAug 27, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) PACING LEAD TRIGGERED AN ALERT FOR LOW IMPEDANCE. IN THE YEARS FOLLOWING, THE LEAD TRIGGERED TWO LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND ELEVATED SENSING INTEGRITY COUNTER (SIC) VALUE. THE DEFIBRILLATION RV LEAD TRIGGERED ALERTS FOR UNDEFINED HIGH IMPEDANCE. ABOUT FIVE YEARS LATER, THE LEAD ALERTED FOR HIGH IMPEDANCE. ADDITIONALLY, THE DEFIBRILLATION SUPERIOR VENA CAVA (SVC) LEAD TRIGGERED AN ALERT FOR HIGH IMPEDANCE. ALL 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 22903622 ↗
• MalfunctionJun 6, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR OUT OF RANGE (OOR) HIGH DEFIBRILLATION IMPEDANCE. 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 19479517 ↗
• InjuryNov 1, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN UPGRADE PROCEDURE, THE SUBCUTANEOUS SUPERIOR VENA CAVA (SVC) DEFIBRILLATION LEAD APPEARED BROKEN ON F LUOROSCOPY.  AFTER THE PROCEDURE, AN X-RAY SHOWED LEAD FRACTURE.  THE LEAD WAS PROGRAMMED OFF.  IT WAS INDICATED THAT DEFIBRILLATION THRESHOLD (DFT) TESTING WAS SUCCESSFUL WITHOUT THE SVC COIL, SO NO FURTHER ACTION WAS PLANNED.  IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED FALL TRAUMA OF THE BACK A COUPLE OF YEARS PRIOR.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049245 ↗
• InjurySep 1, 2023Fracture; Low impedance; Fracture; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS SUSPECTED TO BE BROKEN AT THE HIGH VOLTAGE COIL DUE TO OUT OF RANGE (OOR) LOW DEFIBRILLATION IMPEDANCES. 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 17672676 ↗
• InjuryJan 27, 2023Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A FRACTURE AND TRIGGERED AN ALERT FOR HIGH 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 16252849 ↗
• InjuryNov 15, 2021Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THERE WAS NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. 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 12811544 ↗
• MalfunctionSep 7, 2021High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) PACING LEAD AND THE RV DEFIBRATION LEAD HAD ALERTS FOR HIGH/UNDEFINED IMPEDANCE. 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 12433425 ↗
• MalfunctionJan 25, 2021Low impedance; Impedance Problem; Low impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) DEFIBRILLATION COIL LEADS AND THE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION COIL LEAD ALL DISPLAY FALLING AND LOW IMPEDANCE. IT WAS NOTED THAT THE PATIENT WAS IN BAD HEART FAILURE AWAITING TRANSPLANT AND THAT THE IMPEDANCES WERE MOST LIKELY DUE TO FLUID BETWEEN THE COILS. THE DEFIBRILLATION COIL 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 11226889 ↗
• InjuryJan 3, 2018Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED AN ALERT TRIGGERED DUE TO A SUDDEN INCREASE IN THE SUPERIOR VENA CAVA (SVC) COIL, WHICH OCCURRED FOLLOWING A LEAD FRACTURE. A RADIOGRAPH AND IMAGING UNDER FLUOROSCOPY SHOWED A COIL FRACTURE. IT WAS ALSO REPORTED THE SVC IMPEDANCE WAS HIGH AND THE PATIENT DESCRIBED A "POKING" FEELING AROUND THE POCKET. A PARTIAL EXPLANT WAS PERFORMED; THE PORTION OF THE LEAD CONNECTED TO THE DEVICE WAS REMOVED AND THE DISTAL PORTION CAPPED. THE LEAD WAS REPLACED, AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7160601 ↗
• InjuryJan 2, 2018Fracture; High impedance; Over-Sensing; Impedance Problem; Fracture; High impedance; Over-Sensing; Impedance Problem

  IT WAS REPORTED THERE WAS A LEAD WARNING, THE LEAD DISPLAYED VARIABILITY IN DEFIBRILLATION IMPEDANCE, THERE WAS AN INCREASE IN THE RIGHT VENTRICULAR LEAD IMPEDANCE AND IT WAS HIGH, THERE WAS A HIGH RATE OF NON-SUSTAINED EPISODES, AND THE SENSING INTEGRITY COUNT WAS NOTED. INTERVENTION IS PLANNED; THE LEAD WILL BE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7157707 ↗
• InjuryJul 5, 2017Material Separation; Low impedance; Electrical Shorting; Material Separation; Low impedance; Electrical Shorting

  IT WAS REPORTED THE LEAD DISPLAYED LOW IMPEDANCE. DURING THE REVISION, THE COIL TOUCHED THE CAN CREATING A SHORT. IT WAS ALSO REPORTED WHEN THE PHYSICIAN TRIED TO RE-POSITION THE COIL DISTALLY, IT UNRAVELED. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6687222 ↗
• InjuryMay 9, 2017Failure to Convert Rhythm; Low impedance; Device-Device Incompatibility; Failure to Convert Rhythm; Low impedance; Device-Device Incompatibility

  IT WAS REPORTED THAT DEFIBRILLATION THRESHOLD TESTING (DFT) FAILED. IT WAS DETERMINED THE ACTIVE COILS WERE IN CLOSE PROXIMITY TO TWO PREVIOUSLY ABANDONED LEADS. THE COILS WERE RE-POSITIONED FURTHER APART AND THE ABANDONED LEADS WERE REMOVED. FOLLOWING, THE DFT WAS SUCCESSFUL. IT WAS ALSO REPORTED THE LEADS DISPLAYED LOW IMPEDANCE. ONE LEAD WAS REMOVED AND REPLACED AND THE OTHER 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 6556104 ↗
• MalfunctionMay 9, 2017Over-Sensing; Over-Sensing

  ADDITIONAL INFORMATION WAS RECEIVED WITH A CONTINUATION OF THE PREVIOUSLY REPORTED EVENT AND THE LEAD DISPLAYED T WAVE OVER-SENSING AND POSSIBLE DOUBLE COUNTING. IT WAS DETERMINED TO MONITOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6555915 ↗