Sprint Quattro Secure S® 6947M72Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00643169550964), received between Feb 9, 2017 and Jul 10, 2026 — classified as 20 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (9 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 18, 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.

• InjuryJul 10, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE. IT WAS FURTHER REPORTED THAT DURING THE COMPETITOR DEVICE CHANGE OUT PROCEDURE, THE RV LEAD COULD NOT BE REMOVED DUE TO THE COMPETITOR DEVICE SETSCREW APPEARED TO BE STRIPPED AND WOULD NOT ENGAGE WITH THE WRENCH TOOL. AS A RESULT, THE PHYSICIAN WAS UNABLE TO SEPARATE THE RV LEAD FROM THE COMPETITOR DEVICE. THE RV LEAD WAS CUT AND CAPPED IN THE POCKET AND A NEW RV LEAD WAS IMPLANTED WITHOUT ANY KNOWN ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25780146 ↗
• MalfunctionMar 31, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). IN ADDITION, THE PATIENT EXPERIENCED SHORTNESS OF BREATH. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 24744957 ↗
• MalfunctionFeb 20, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. 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 24401302 ↗
• InjurySep 10, 2025Signal Artifact/Noise; Fracture; Over-Sensing; Signal Artifact/Noise; Fracture; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED (HRNS) EPISODES AND SENSING INTEGRITY COUNTER (SIC). IN ADDITION, A LEAD NOISE WARNING TRIGGERED AND 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 23017476 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST IMPLANT PROCEDURE, THE PATIENT DEVELOPED AN INFECTION. THE SOURCE OF THE INFECTION WAS NOTED TO BE BACTEREMIA. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 22635446 ↗
• InjuryFeb 29, 2024Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED VARIABLE PACING IMPEDANCE TO HIGH/UNDEFINED LEVELS. A LOW VOLTAGE FRACTURE WAS SUSPECTED. THE RV 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 18808147 ↗
• InjuryApr 28, 2023Signal Artifact/Noise; Failure to Capture; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; High Capture Threshold; Signal Artifact/Noise; Failure to Capture; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS OVERSENSING NOISE AND DELIVERED INAPPROPRIATE THERAPY. THE LEAD HAD HIGH RV THRESHOLDS AND WAS UNABLE TO CAPTURE DUE TO A CONFIRMED FRACTURE. IT WAS NOTED THAT THERE WAS AN OUT OF RANGE (OOR) IMPEDANCE WARNING FOR HIGH/UNDEFINED RVTIP TO RVCOIL PACING IMPEDANCE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 16832902 ↗
• InjuryMar 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD BECOME DISLODGED DUE TO TWIDDLER'S SYNDROME. IT WAS NOTED THAT WHEN THE PATIENT TURNED THE DEVICE OR LEAD WOULD MOVE, THE PATIENT TRIED TO STOP IT BY TWIRLING THE LEADS. THE LEAD WAS EXPLANTED AND REPLACE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Twiddlers Syndrome

  MAUDE report 16478673 ↗
• InjuryNov 1, 2022Signal Artifact/Noise; Fracture; Impedance Problem; Signal Artifact/Noise; Fracture; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE ON THE PACE SENSE PORTION OF THE LEAD. IN ADDITION A JUMP IN PACING IMPEDANCE WAS NOTED. A LEAD FRACTURE WAS CONFIRMED. 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 15709372 ↗
• InjuryAug 15, 2022Failure to Capture; Under-Sensing; Device Dislodged or Dislocated; High Capture Threshold; Failure to Capture; Under-Sensing; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED SEEN ON FLUOROSCOPY POST IMPLANT. THE LEAD HAD HIGH THRESHOLDS WITH NO CAPTURE. THE LEAD HAD UNDERSENSING. THE LEAD WAS REVISED AND REPOSITIONED. 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 15230181 ↗
• InjuryFeb 23, 2022Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR HIGH UNDEFINED SUPERIOR VENA CAVA (SVC) IMPEDANCE. SVC FRACTURE WAS CONFIRMED. 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 13585428 ↗
• MalfunctionDec 16, 2021Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXTREMELY TWISTED AND KINKED BETWEEN THE TWO COILS. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019216 ↗
• InjuryOct 15, 2021Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS FURTHER REPORTED THAT THE SENSING PARAMETERS WERE REPROGRAMMED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 12641292 ↗
• InjuryOct 11, 2021High impedance; Over-Sensing; Impedance Problem; High impedance; Over-Sensing; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE LEAD HAD UNDEFINED HIGH PACING IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605666 ↗
• MalfunctionMar 31, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE WHEN THE PHYSICIAN WAS TUNNELING THE RIGHT VENTRICULAR (RV) LEAD, THE PIN BROKE. ANOTHER LEAD WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595030 ↗
• InjuryJan 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT BOTH THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS DISLODGED DUE TO TWIDDLER'S SYNDROME. THE LEFT SUBCLAVIAN VEIN WAS NOTED TO BE OCCLUDED. THE LEADS WERE NOTED TO HAVE BEEN ABANDONED. THE LEADS WERE EXPLANTED AND REPLACED ON THE OPPOSITE SIDE A FEW DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Obstruction/Occlusion; Twiddlers Syndrome

  MAUDE report 11227265 ↗
• MalfunctionJan 4, 2021Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER HAVING RECEIVED A SHOCK. A REMOTE TRANSMISSION INDICATED A VENTRICULAR UNDERSENSED BEAT NOTED ON ELECTROGRAM (EGM). 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 11109148 ↗
• MalfunctionDec 10, 2020Over-Sensing; High Capture Threshold; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A LEAD INTEGRITY ALERT (LIA) TRIGGERED BY HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). IN ADDITION, THE LEAD HAD HIGH THRESHOLDS AND T-WAVE OVERSENSING (TWOS) AND OVERSENSING WAS NOTED ON STORED ELECTROGRAMS (EGM). 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 10987834 ↗
• InjuryJul 1, 2020Fracture; High impedance; Inappropriate/Inadequate Shock/Stimulation; Fracture; High impedance; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A CONFIRMED FRACTURE. THE LEAD HAD HIGH AND UNDEFINED PACING IMPEDANCE AND DELIVERED AN INAPPROPRIATE SHOCK. THE LEAD WAS INITIALLY PROGRAMMED OFF AND SUBSEQUENTLY EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 10220539 ↗
• InjuryMar 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A POSSIBLE FRACTURE. THE LEAD WAS 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 9868499 ↗
• MalfunctionMar 11, 2020Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A LOW IMPEDANCE OUT OF RANGE ALERT. 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 9819828 ↗
• InjuryJan 22, 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 INFECTED. THE CRT-D SYSTEM REMAINS IN USE, BUT AN EXTRACTION PROCEDURE WAS PLANNED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9616067 ↗
• InjuryFeb 19, 2019Signal Artifact/Noise; Fracture; High impedance; Signal Artifact/Noise; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE MEASUREMENTS FOR BOTH THE SUPERIOR VENA CAVA (SVC) AND RIGHT VENTRICULAR (RV) COILS. IT WAS FURTHER REPORTED THAT THE SVC COIL WAS FRACTURED AND HAD HIGH UNDEFINED IMPEDANCE. ISOMETRICS SHOWED THAT THE SVC TO RV COIL WAS NOISY. THE LEAD WAS REPROGRAMMED AND PARTIALLY REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8351296 ↗
• InjuryDec 5, 2018Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT A CAREALERT INDICATED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY AFTER OVERSENSING NOISE. THERE WERE OTHER EPISODES THAT INDICATED ONE TO TWO SECONDS OF OVERSENSING. IT WAS ALSO NOTED THAT APPROXIMATELY A WEEK EARLIER THE RIGHT VENTRICULAR (RV) LEAD HAD A LEAD INTEGRITY WARNING TRIGGERED DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 8134970 ↗
• InjurySep 17, 2018High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THERE WAS HIGH THRESHOLD ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED DURING THE RV LEAD REPLACEMENT, THE RIGHT ATRIAL (RA) LEAD DISLODGED. IT WAS NOTED THE LEAD WAS PREVIOUSLY TURNED OFF DUE TO ATRIAL STANDSTILL. THE LEAD WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7882864 ↗