NA 6996SQ58 (UDI 00643169541177)Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00643169541177), received between Dec 7, 2017 and Aug 7, 2026 — classified as 1 death, 33 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (17 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 49 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Device Dislodged or Dislocated; Positioning Problem

  It was reported that approximately one week post implant, the Sub-Q Defibrillation lead experienced a positioning/placement issue and dislodged. The Sub-Q Defibrillation 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 50176843 ↗
• MalfunctionApr 14, 2026High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED JUMPS IN DEFIBRILLATION IMPEDANCE AND TRIGGERED MULTIPLE HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. 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 24877839 ↗
• MalfunctionMar 25, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING RESULTING IN T-WAVE OVERSENSING (TWOS).  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 24688018 ↗
• MalfunctionDec 1, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED SENSING INTEGRITY COUNTER (SIC) EPISODES. 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 23685025 ↗
• MalfunctionOct 24, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE DEFIBRILLATION COIL OF THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED VARYING 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 23379450 ↗
• InjuryOct 20, 2025Signal Artifact/Noise; High impedance; Connection Problem; Impedance Problem; Signal Artifact/Noise; High impedance; Connection Problem; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEEN IN FOLLOW UP AND THE ICD WAS REPROGRAMMED TO INCLUDE ALL VECTORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23339505 ↗
• MalfunctionJul 16, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED BY THE PATIENT'S REPRESENTATIVE THAT THE PATIENT HEARD AN ALERT TONE THE NIGHT PRIOR AND WENT TO THE EMERGENCY DEPARTMENT (ED). THE PATIENT'S REPRESENTATIVE NOTED THAT THE ED STAFF INTERROGATED THE DEVICE AND REVIEWED THE TRANSMISSION REPORT. THE STAFF NOTED TO THE PATIENT'S REPRESENTATIVE THAT THERE WAS "A LEAD WARNING FOR IMPEDANCE". THE PATIENT'S REPRESENTATIVE NOTED THAT THE ALERT WAS SOUNDING "EVERY FEW HOURS" AND WAS MAKING SLEEPING DIFFICULT FOR THE PATIENT. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sleep Dysfunction

  MAUDE report 22521284 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ENDOCARDITIS INFECTION. BACTEREMIA WAS NOTED AND VEGETATION WAS OBSERVED ON THE VALVES AND LEADS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Endocarditis; Medical device site infection

  MAUDE report 22006235 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST IMPLANT, THE PATIENT EXPERIENCED SERRATIA BACTEREMIA AND WAS TREATED WITH ANTIBIOTICS. APPROXIMATELY TWO MONTHS LATER, THE PATIENT EXPERIENCED SWELLING AND A LARGE BLISTER AT THE DEVICE SITE. THE PATIENT ALSO EXPERIENCED ENDOCARDITIS. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. A PREVIOUSLY ABANDONED LEADLESS PACEMAKER WAS REACTIVATED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Blister; Endocarditis; Swelling/ Edema

  MAUDE report 21912941 ↗
• InjuryMar 10, 2025Fracture; Impedance Problem; Fracture; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED VARYING IMPEDANCE VALUES. IT WAS SUSPECTED THAT THE LEAD HAD A FRACTURE ON THE HIGH VOLTAGE RV COIL. 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 21559467 ↗
• InjuryFeb 25, 2025Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND SPIKED RV COIL IMPEDANCE DUE TO AN RV COIL FRACTURE. THE 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 21462855 ↗
• InjuryFeb 19, 2025Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT AN IMPEDANCE WARNING TRIGGERED FOR THE RIGHT VENTRICULAR (RV) LEAD DUE TO HIGH OUT OF RANGE RV DEFIBRILLATION IMPEDANCE. AN RV COIL LEAD FRACTURE WAS CONFIRMED WHEN TESTED IN OFFICE AND THEN IN THE ELECTROPHYSIOLOGY (EP) LAB. THE RV 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 21417125 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SEVENTEEN WEEKS POST IMPLANT, THE PATIENT EXPERIENCED AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET KL EBSIELLA INFECTION AND WOUND DEHISCENCE. THE ICD AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND REPLACED, AND THE SUBCUTANEOUS DEFIBRILLATION LEAD WAS CAPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 21055594 ↗
• MalfunctionDec 3, 2024Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE SUPERIOR VENA CAVA (SVC) COIL LEAD EXHIBITED A GRADUAL RISE IN IMPEDANCE LIKELY RELATED TO MINERALIZATION. THEN SUDDEN DROPS IN IMPEDANCE WERE NOTED WITH NOW A SUBSEQUENT RISE IN IMPEDANCE AGAIN. IT WAS FURTHER REPORTED THAT THE DROPS IN IMPEDANCE WERE DUE TO SHOCKS THAT WERE DELIVERED AT THE TIME CLEARING THE MINERALIZATION FROM THE COIL. 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 20835775 ↗
• InjuryOct 15, 2024Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) SUBCUTANEOUS LEAD EXHIBITED HIGH DEFIBRILLATION IMPEDANCE AND LEAD FRACTURE WAS SUSPECTED. THE 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 20450987 ↗
• InjurySep 5, 2024Low impedance; Positioning Problem; Low impedance; Positioning Problem

  IT WAS FURTHER REPORTED THAT REPROGRAMMING OCCURRED. DETECTIONS AND THERAPIES WERE PROGRAMMED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20151060 ↗
• InjuryAug 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED, THAT THE SUBCUTANEOUS DEFIBRILLATION LEAD DISLODGED. THE COIL WAS SEEN TO BE RETRACTED AND ALMOST OUTSIDE THE POCKET. THE LEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED, AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20070945 ↗
• InjuryAug 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS A CONFIRMED FRACTURE OF THE HIGH VOLTAGE COIL OF THE SUBCUTANEOUS RIGHT VENTRICULAR (RV) LEAD. 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 20010244 ↗
• MalfunctionJul 25, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT DUE TO HIGH OUT OF RANGE (OOR) SUPERIOR VENA CAVA (SVC) IMPEDANCE. IT WAS NOTED THAT THE SVC IMPEDANCE TRENDS WERE VARIABLE. 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 19830395 ↗
• InjuryJul 8, 2024Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE SUPERIOR VENA CAVA (SVC) LEAD AND RIGHT VENTRICULAR (RV) LEAD DISPLAYED ABRUPT INCREASES IN DEFIBRILLATION IMPEDANCE TRIGGERING OUT OF RANGE (OOR) ALERTS FOR HIGH/UNDEFINED SVC AND RV COIL IMPEDANCES. ISOMETRICS AND POCKET MANIPULATION WERE UNABLE TO REPRODUCE OOR IMPEDANCES OR NOISE. THE DEVICE DETECTIONS WERE TURNED OFF DUE TO SUSPECTED SVC AND RV COIL FRACTURES. BOTH LEADS WERE 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 19690259 ↗
• InjuryJun 7, 2024Signal Artifact/Noise; Over-Sensing; Under-Sensing; Signal Artifact/Noise; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) SUBCUTANEOUS DEFIBRILLATION LEAD EXHIBITED OVERSENSING, UNDERSENSING, NOISE, AND A L EAD INTEGRITY ALERT (LIA) WAS TRIGGERED BY SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES. IT WAS FURTHER REPORTED THAT THE LEAD WAS PLUGGED INTO THE PACING PORT. A NEW RV PACING LEAD WAS IMPLANTED, AND THE RV SUBCUTANEOUS DEFIBRILLATION LEAD WAS MOVED TO THE DEFIBRILLATION PORT AND REMAINS IN USE FOR HIGH VOLTAGE THERAPY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19492981 ↗
• InjuryMay 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY FIVE WEEKS POST IMPLANT IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) SUBCUTANEOUS LEAD HAD MIGRATED. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19282144 ↗
• MalfunctionApr 23, 2024Low impedance; Impedance Problem; Low impedance; Impedance Problem

  IT WAS REPORTED THAT THE THE SUBCUTANEOUS DEFIBRILLATION COIL LEAD EXHIBITED A DECREASE IN IMPEDANCE TO LOW LEVELS. IMPEDANCE ALERTS WERE DISABLED. A GRADUAL DECREASE IN PACING IMPDEANCE ON THE RIGHT VENTRICULAR (RV) LEAD WAS ALSO NOTED. 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 19166746 ↗
• InjuryApr 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE PNEUMOTHORAX WAS ALSO THOUGHT TO BE RELATED TO THE TUNNELING TOOL USED DURING PLACEMENT OF THE RV LEAD.

  Patient problems: Pneumothorax

  MAUDE report 19072404 ↗
• MalfunctionDec 15, 2023High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A DEFIBRILLATION IMPEDANCE SPIKE. THE SPIKE CAUSED HIGH OUT OF RANGE (OOR) 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 18339765 ↗