NA 6996SQ58 (UDI 00613994568021)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00613994568021), received between May 9, 2017 and Aug 27, 2026 — classified as 1 death, 16 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (10 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that Right Ventricular (RV) lead and adaptor exhibited a failure. The lead and adaptor 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 50475534 ↗
• InjuryJan 12, 2026Impedance Problem; Unstable Impedance

  IT WAS FURTHER REPORTED THAT SUBCUTANEOUS LEAD IMPEDANCES WERE VARIABLE AND THE LEAD WAS CAPPED. AFTER THE LEAD WAS CAPPED IT WAS NOTED THAT THE RV LEAD DEFIBRILLATION IMPEDANCES REMAINED HIGHER THAN EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24034528 ↗
• InjuryApr 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS CONFIRMED TO BE FRACTURED AT THE HIGH VOLTAGE PORTION OF THE LEAD. AN X-RAY CONFIRMED A COMPLETE FRACTURE. THE LEAD WAS PARTIALLY 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 19031602 ↗
• MalfunctionFeb 1, 2024Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR LOW RV COIL 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 18627254 ↗
• MalfunctionMay 30, 2023Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD LOW PACING IMPEDANCE FOR BOTH THE CURRENT AND PREVIOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). ADDITIONALLY, IT WAS NOTED THAT UPON THE EXPLANT OF THE PREVIOUS ICD THERE WAS A HEAVILY CALCIFIED ENCAPSULATION THAT WAS REMOVED, IT WAS SUSPECTED THAT THE CALCIFICATION MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE LOW PACING IMPEDANCE. THE LEAD REMAINS IN USE AND WILL CONTINUE TO BE MONITORED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020996 ↗
• InjuryMay 30, 2023Failure to Capture; Fracture; High impedance; Over-Sensing; Failure to Capture; Fracture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR HIGH/UNDEFINED PACING IMPEDANCE AND THE SUBCUTANEOUS DEFIBRILLATION COIL TRIGGERED AN ALERT FOR HIGH/UNDEFINED DEFIBRILLATION IMPEDANCE. THE SUBCUTANEOUS DEFIBRILLATION COIL IS SUSPECTED TO BE FRACTURED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERAPIES WERE PROGRAMMED OFF AND THE PATIENT WAS FITTED WITH A WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17019614 ↗
• InjuryDec 13, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO A LEAD MALFUNCTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968736 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE MONTH POST GENERATOR CHANGE, THE PATIENT¿S INCISION BEGAN TO OPEN ON ONE END AND THE DEVICE WAS VISIBLE. THE DEVICE POCKET WAS FOUND TO BE INFECTED AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS THEN EXPLANTED. THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 15508029 ↗
• MalfunctionMay 20, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT RECEIVED A SHOCK DUE TO POSSIBLE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR) THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). IN ADDITION, THE RIGHT VENTRICULAR (RV) LEADS TRIGGERED ALERTS FOR HIGH UNDEFINED RV DEFIBRILLATION AND RVTIP TO RV COIL LEAD IMPEDANCE AND FOR HIGH THRESHOLDS. PREVIOUS HIGH RV THRESHOLDS WERE NOTED ON THE LEAD TREND. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND 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 14463158 ↗
• 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 11226927 ↗
• 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 11226912 ↗
• InjuryOct 8, 2020Fracture; Impedance Problem; Fracture; Impedance Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD AN IMPEDANCE ISSUE AND A POSSIBLE FRACTURE. THE SUPERIOR VENA CAVA (SVC) PORT WAS PROGRAMMED OFF AND THE LEAD WAS SUBSEQUENTLY EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10651374 ↗
• MalfunctionMay 27, 2020Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD OVERSENSING OF NOISE. 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 10092783 ↗
• InjuryMay 11, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE TO REPAIR THE AORTIC VALVE THE SUBCUTANEOUS LEAD WAS CUT. THE LEAD WAS PARTIALLY 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 10042714 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND HAD THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXPLANTED. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL NETWORK CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9812768 ↗
• MalfunctionOct 16, 2019Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT¿S RIGHT VENTRICULAR (RV) SUBCUTANEOUS HIGH VOLTAGE LEAD EXHIBITED FLUCTUATION IN HIGH VOLTAGE COIL IMPEDANCE. THE RV SUBCUTANEOUS HIGH VOLTAGE 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 9199557 ↗
• MalfunctionApr 4, 2019Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT DURING USE OF THE RIGHT VENTRICULAR (RV) LEAD T-WAVE OVERSENSING (TWOS) NOTED ON NON-SUSTAINED TACHYCARDIA (NST) EPISODE(S). THE RV 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 8484349 ↗
• DeathMar 13, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT IS DECEASED. AN ATTORNEY REPRESENTING THE PATIENT'S FAMILY HAVE MADE AN ALLEGATION THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM MAY HAVE BEEN INVOLVED IN THE PATENT'S DEATH.

  Patient problems: Death

  MAUDE report 8417891 ↗
• InjuryMar 8, 2019Low impedance; Low impedance

  IT WAS FURTHER REPORTED/CLARIFIED THAT THE PATIENT HAD 2 REVISION PROCEDURES. DURING THE FIRST PROCEDURE, ONE SUBCUTANEOUS LEAD WAS REMOVED AND REPLACED WITH AN INTRAVENOUS RIGHT VENTRICULAR (RV) LEAD. THE FOLLOWING DAY, THE 2ND SUBCUTANEOUS LEAD WAS REMOVED AND REPLACED WITH A NEW SUBCUTANEOUS LEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8405819 ↗
• InjuryMar 8, 2019Low impedance; Low impedance

  IT WAS FURTHER REPORTED/CLARIFIED THAT THE PATIENT HAD 2 REVISION PROCEDURES. DURING THE FIRST PROCEDURE, ONE SUBCUTANEOUS LEAD WAS REMOVED AND REPLACED WITH AN INTRAVENOUS RIGHT VENTRICULAR (RV) LEAD. THE FOLLOWING DAY, THE 2ND SUBCUTANEOUS LEAD WAS REMOVED AND REPLACED WITH A NEW SUBCUTANEOUS LEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8405807 ↗
• InjuryAug 6, 2018High impedance; Application Program Problem; Impedance Problem; High impedance

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) DEFIBRILLATION SUB-Q COIL LEAD DISPLAYED A JUMP IN RV DEFIBRILLATION COIL IMPEDANCE WHICH HAD TRIGGERED AN ALERT FOR HIGH/UNDEFINED IMPEDANCE. IT WAS NOTED THAT THE IMPEDANCE ALERTS AND HIGH VOLTAGE THERAPIES WERE PROGRAMMED "OFF." THE LEAD REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7753665 ↗
• InjuryJul 27, 2018Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD ALERTED FOR LOW IMPEDANCE ON THE SUBCUTANEOUS HIGH VOLTAGE COIL. THE LEAD WAS REVISED AND REMOVED. A NEW INTRAVENOUS LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7727759 ↗
• InjuryJun 8, 2018Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD HIGH/UNDEFINED PACING IMPEDANCE, AND HIGH RV/SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE. THE LEAD WAS 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 7581795 ↗
• InjuryApr 10, 2018Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE SUBCUTANEOUS LEAD EXHIBITED VARYING, HIGH, AND UNDEFINED IMPEDANCE INTERMITTENTLY DUE TO A FRACTURE. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD. FOLLOW UP YIELDED NO INFORMATION. THE RV 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 7415657 ↗
• InjuryJan 26, 2018Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO DOUBLE COUNTING PACED COMPLEXES AND VENTRICULAR TACHYCARDIAS/PREMATURE VENTRICULAR CONTRACTIONS. A LEAD INTEGRITY ISSUE WAS NOT OBSERVED. THE LEAD WAS REPROGRAMMED AND 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 7222602 ↗