NA 6996SQ58 (UDI 00721902183072)Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00721902183072), received between Apr 6, 2017 and May 21, 2026 — classified as 41 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (21 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND HIGH SENSING INTEGRITY COUNTER (SIC). IT WAS ALSO REPORTED THAT THE RV LEAD EXHIBITED OVERSENSING ON A STORED EPISODE, RESULTING IN MISCLASSIFICATION OF EPISODE TYPE AND NOISE. IT WAS FURTHER REPORTED THAT THERE WERE HIGH OUT OF RANGE RV PACING IMPEDANCE, RV DEFIBRILLATION IMPEDANCE AND SUPERIOR VENA CAVA (SVC) DEFIBRILLATION 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 25249839 ↗
• MalfunctionOct 23, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH/UNDEFINED IMPEDANCE ON THE SUPERIOR VENA CAVA (SVC) COIL. 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 23368760 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. NO FURTHER PATIENT C OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22783470 ↗
• InjuryJan 5, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE SUPERIOR VENA CAVA (SVC) LEAD TRIGGERED MULTIPLE ALERTS FOR HIGH UNDEFINED SVC IMPEDANCE THAT MEASURED OUT OF RANGE (OOR). THE ALERT TONE FOR SVC IMPEDANCE OOR WAS PROGRAMMED OFF AND 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 18453052 ↗
• InjuryOct 25, 2023Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE SUBCUTANEOUS RIGHT VENTRICULAR (RV) LEAD HAD A HIGH VOLTAGE EXTRAVASCULAR COIL FRACTURE AND THE LEFT VENTRICULAR (LV) LEAD HAD A LOW VOLTAGE FRACTURE. WHEN THE LEADS WERE TESTED WITH AN ANALYZER THE RV LEAD PACING IMPEDANCE WAS HIGH AND THE LV LEAD BIPOLAR IMPEDANCE WAS ALSO HIGH. THE RV LEAD WAS CAPPED AND THE LV 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 18002123 ↗
• InjurySep 6, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE ICD SYSTEM WAS EXPLANTED AND REPLACED DUE TO AN UNSPECIFIED PRODUCT PERFORMANCE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17689935 ↗
• MalfunctionJun 30, 2023Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT REVIEW OF A REMOTE TRANSMISSION SHOWED THE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION LEAD HAD TRIGGERED AN ALERT FOR HIGH OUT OF RANGE (OOR) IMPEDANCE ABOVE THE PROGRAMMED ALERT THRESHOLD, AND REVIEW OF LEAD TRENDS SHOWED BOTH THE SVC DEFIBRILLATION LEAD AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITING A GRADUAL RISE IN IMPEDANCE. BOTH DEFIBRILLATION 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 17238279 ↗
• InjuryMar 8, 2022Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD LOW PACING IMPEDANCE AND WAS CAPPED AND REPLACED. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH IMPEDANCE AND WAS OVERSENSING NOISE. THE LV LEAD WAS ALSO CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13686226 ↗
• InjuryJan 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SUBCUTANEOUS DEFIBRILLATOR COIL HAD FRACTURED, VISUALIZED ON FLUOROSCOPY. THE LEAD WAS PARTIALLY REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13164276 ↗
• InjuryMar 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBCUTANEOUS HIGH VOLTAGE RIGHT VENTRICULAR (RV) LEAD HAD ERODED THOUGH THE SKIN. THE LEAD WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Skin Erosion

  MAUDE report 11391939 ↗
• InjuryNov 18, 2020Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT HEARD ALERTS FROM THE DEVICE AND WAS ADMITTED TO THE HOSPITAL. A CHECK ON THE DEVICE SHOWS ALERTS FROM THE RIGHT VENTRICULAR (RV) LEAD FOR HIGH IMPEDANCE ON THE RV COIL, AND HIGH IMPEDANCE ON THE SUBCUTANEOUS HIGH VOLTAGE SUPERIOR VENA CAVA (SVC) LEAD. THE SVC LEAD ALSO HAD INCREASED IMPEDANCE MEASUREMENTS AND A FRACTURE WAS SUSPECTED. THE SVC LEAD WAS PROGRAMMED OFF AND REMAINS IN THE PATIENT. DEFIBRILLATION THRESHOLD TESTING (DFT) WAS SUCCESSFULLY PERFORMED ON THE RV COIL, AND IT 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 10861186 ↗
• InjurySep 17, 2020High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE SUPERIOR VENA CAVA (SVC) COIL OF THE RIGHT VENTRICULAR (RV) SUBCUTANEOUS LEAD HAD HIGH/UNSTABLE IMPEDANCE. THE RV COIL OF THE RV LEAD WAS ALSO NOTED TO HAVE UNSTABLE IMPEDANCE. THE PATIENT RECEIVED A LIFE VEST AND THE LEAD WAS TURNED OFF UNTIL IT CAN BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10547598 ↗
• InjuryJul 10, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT¿S SUBCUTANEOUS RIGHT VENTRICULAR (RV) DEFIBRILLATOR LEAD WAS COMPLETELY FRACTURED IN THE AREA OF THE POCKET. THE SUBCUTANEOUS RV DEFIBRILLATOR LEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10256969 ↗
• InjuryJun 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HAD AN INFECTION WITH A POCKET OF PUS NOTED AT THE DEVICE SITE. CULTURES WERE TAKEN AND ANTIBIOTIC TREATMENT WAS NECESSARY. THE DEVICE AND LEADS WERE EXPLANTED AND WILL BE REPLACED IN THE FUTURE. DURING THE EXTRACTION, THE LEFT VENTRICULAR (LV) LEAD BROKE OFF AND REMAINS IN THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discharge; Unspecified Infection

  MAUDE report 10144643 ↗
• InjuryMar 6, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DEVELOPED A FRACTURE. THE PROXIMAL PORTION OF THE SUBCUTANEOUS LEAD WAS REMOVED FROM THE POCKET AND THE DISTAL PORTION REMAINS IN-SITU ABANDONED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9799849 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE INFECTED. THE LEADS WERE INACTIVATED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9681770 ↗
• InjuryFeb 7, 2020Pacing Problem; Adverse Event Without Identified Device or Use Problem; Pacing Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE INFECTED. THE LEADS WERE INACTIVATED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9681758 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE ORIGINAL SOURCE OF THE INFECTION WAS NOTED TO BE IN THE DEVICE POCKET. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE, RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) HIS BUNDLE LEADS WERE EXPLANTED. THE RIGHT VENTRICULAR (RV) AND EPICARDIAL LEADS WERE PARTIALLY EXPLANTED. A NEW IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9565973 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WAS REMOVED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9410476 ↗
• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 9099927 ↗
• InjurySep 19, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD HAD FRACTURED. 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 9088356 ↗
• InjuryAug 6, 2019Adverse 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 8864545 ↗
• MalfunctionJul 18, 2019Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCES AND WAS POSSIBLY FRACTURED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8805017 ↗
• MalfunctionJul 11, 2019Low impedance; Low impedance

  IT WAS REPORTED THAT THE SUBCUTANEOUS LEAD PATCH THAT WAS PLUGGED INTO THE RIGHT VENTRICULAR (RV) SUPERIOR VENA CAVA (SVC) COIL PORT HAD LOW IMPEDANCE. 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 8779266 ↗
• InjuryApr 16, 2019Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE SUPERIOR VENA CAVA (SVC) PORTION OF THE LEAD TRIGGERED AN ALERT FOR UNDEFINED HIGH IMPEDANCE. THE LEAD ALSO HAD A CONFIRMED FRACTURE. THE LEAD WAS PROGRAMMED OFF AND IS SCHEDULED FOR A REPLACEMENT IN THE NEAR FUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8520607 ↗