Sprint Quattro Secure® 6947M72 (UDI 00643169082281)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00643169082281), received between Dec 7, 2017 and Mar 24, 2025 — classified as 1 death, 18 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (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. 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2025Adverse 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 INFECTION. THE SOURCE OF THE INFECTION WAS LISTED AS BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 21679005 ↗
• InjuryMar 13, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE AND OVERSENSING. THE RV LEAD WAS REPROGRAMMED AND THERAPIES WERE TURNED OFF BEFORE THE LEAD WAS ULTIMATELY 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 21594227 ↗
• MalfunctionNov 8, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). 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 20642971 ↗
• MalfunctionOct 28, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE PATIENT HAD A FOLLOW-UP VISIT WITH THEIR CARDIOLOGIST AFTER THE ALERT AND THERE WAS NO FURTHER INFORMATION ON THE ALERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20546180 ↗
• InjuryMay 15, 2024Failure to Capture; Fracture; High impedance; Over-Sensing; Decreased Sensitivity; Impedance Problem; Failure to Capture; Fracture; High impedance; Over-Sensing; Decreased Sensitivity; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED INTERMITTENT OVERSENSING ON HIGH RATE NON-SUSTAINED EPISODES AND TRIG GERED LEAD INTEGRITY ALERTS (LIAS) FOR SENSING INTEGRITY COUNTER (SIC) AND PACING IMPEDANCE VARIATION. 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 19321302 ↗
• DeathMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS DECEASED APPROXIMATELY 10 YEARS AFTER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM IMPLANT. THE CAUSE OF DEATH WAS PROVIDED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS BACTEREMIA. THE SOURCE OF THE BACTEREMIA WAS REQUESTED AND NOT RECEIVED.

  Patient problems: Bacteremia; Drug Resistant Bacterial Infection

  MAUDE report 19237262 ↗
• InjuryMar 1, 2024Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) / RECOMMENDED REPLACEMENT TIME (RRT) AND EXHIBITED CHARGE CIRCUIT TIMEOUT.  THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED LEAD INTEGRITY ALERT (LIA) FOR HIGH RV BIPOLAR AND RV TIP TO COIL IMPEDANCE AND SENSING INTEGRITY COUNTER (SIC). THE RV LEAD ALSO WAS OVERSENSING AS NOTED ON CURRENT ELECTROGRAMS (EGM). THE  DEVICE AND 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; Shock from Patient Lead(s)

  MAUDE report 18822750 ↗
• MalfunctionJan 23, 2024Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING NOISE AND TRIGGERED LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC).  THE LEAD ALSO EXHIBITED OUT OF RANGE (OOR) HIGH RV BIPOLAR  AND RV TIP TO COIL LEAD 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 18566769 ↗
• InjuryJun 14, 2023High impedance; High impedance

  IT WAS REPORTED BY THE PATIENT THAT THEIR DEFIBRILLATOR EMITTED SEVERAL HIGH/LOW FREQUENCY TONES. A TRANSMISSION REPORT INDICATED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED WARNINGS FOR UNDEFINED HIGH PACING IMPEDANCE, OUT OF RANGE (OOR) HIGH RV DEFIBRILLATION AND SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE. 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 17130554 ↗
• InjuryApr 3, 2023Fracture; High impedance; Material Protrusion/Extrusion; Fracture; High impedance; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A FRACTURE AND EXHIBITED UNDEFINED HIGH DEFIBRILLATION IMPEDANCE AND UNDEFINED HIGH SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE. LEAD REMOVAL WAS ATTEMPTED. THE LEAD CONDUCTORS HAD EXTERNALIZED AND IT WAS UNABLE TO COMPLETE LASER LEAD EXTRACTION. 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 16671177 ↗
• InjuryNov 4, 2022Over-Sensing; Impedance Problem; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM FOR AN AUDIBLE ALERT. IT WAS NOTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO SENSING INTEGRITY COUNTER (SIC) AND IMPEDANCE VARIATION. THERE WERE NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODES AND OVERSENSING OBSERVED. THE LEAD WAS INACTIVATED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15732076 ↗
• InjurySep 2, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH UNDEFINED OUT OF RANGE (OOR) PACING IMPEDANCE. THE LEAD WAS EXPLANTED AND REPLACED. DURING THE REPLACEMENT PROCEDURE, A TEAR OF THE SUPERIOR VENA CAVA (SVC) OCCURRED REQUIRING THE CHEST CAVITY TO BE OPENED FOR REPAIR. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 15349023 ↗
• InjuryMar 19, 2022Signal Artifact/Noise; Over-Sensing; Impedance Problem; Signal Artifact/Noise; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THERE WAS A LEAD INTEGRITY ALERT (LIA) ON THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED BY HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). IT WAS ALSO NOTED THAT THERE WAS OVERSENSING ON THE RV LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13825828 ↗
• InjuryMay 26, 2020Signal Artifact/Noise; Fracture; Over-Sensing; Impedance Problem; High Capture Threshold; Signal Artifact/Noise; Fracture; Over-Sensing; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT HEARD AN ALERT AND WENT TO THE CLINIC. IT WAS FOUND THAT THE ALERT WAS TRIGGERED BY SHORT V-V INTERVALS AND VARIATION IN RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE. REPROGRAMMING WAS PERFORMED. A WEEK LATER ANOTHER ALERT WAS TRIGGERED FOR THE SAME ISSUE. THE RV LEAD WAS SUSPECTED TO BE FRACTURED. NON-SUSTAINED EPISODES AND HIGH RV THRESHOLD WERE ALSO OBSERVED. OVERSENSING WAS PRESENT DURING TESTING. REPROGRAMMING WAS PERFORMED, AND THE LEAD WAS CAPPED A FEW DAYS LATER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10089321 ↗
• MalfunctionMar 9, 2020Break; Pacing Problem; Impedance Problem; Break; Pacing Problem; Impedance Problem

  IT WAS FURTHER REPORTED BY THE PATIENT'S PHYSICIAN THAT THE LEAD ISSUE WAS INCREASED IMPEDANCE AND PACING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9806724 ↗
• InjuryJan 28, 2020Adverse 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 AND WILL NOT BE REPLACED DUE TO A POCKET INFECTION CAUSING THE DEVICE TO EXTERNALIZE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 9639135 ↗
• InjuryJan 14, 2020Adverse 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 REMOVED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9589638 ↗
• InjuryMay 21, 2019Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED DUE TO OVERSENSING WITH SENSING INTEGRITY COUNTER (SIC) EPISODES. THE LEAD THERAPIES WERE PROGRAMMED OFF. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 8630301 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE DEVICE AND LEADS WERE EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8550246 ↗
• InjuryApr 19, 2019Fracture; Impedance Problem; Fracture; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED FLUCTUATING IMPEDANCES ON RV AND SUPERIOR VENA CAVA (SVC) COILS. IT WAS DETERMINED THAT THE RV LEAD HAD FRACTURED. INTERVENTION TOOK PLACE AND 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 8531460 ↗
• MalfunctionMar 21, 2019Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND SHORT V-V INTERVALS. 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 8441082 ↗
• InjuryNov 19, 2018Adverse 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 DEVICE EXPLANTED AND THEIR LEAD CAPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8083201 ↗
• InjuryJun 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION FROM (B)(6). THEIR IMPLANTABLE CARDIOVE RTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND ANTIBIOTICS WERE ADMINISTERED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7632352 ↗
• InjuryDec 7, 2017Intermittent Capture; Fracture; Intermittent Capture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A POSSIBLE LEAD FRACTURE. THE LEAD ALSO HAD INTERMITTENT CAPTURE AT MAX OUTPUTS. THE LEAD WAS PROGRAMMED OFF, AND TWO WEEKS LATER EXPLANTED 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 7097681 ↗