Sprint Quattro Secure S® 6935M72 (UDI 00643169309784)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169309784), received between Apr 6, 2017 and Sep 9, 2025 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 8, 2021Class IITerminated

   The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."

   Z-0390-2022 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2025Signal Artifact/Noise; Intermittent Capture; Fracture; High impedance; Over-Sensing; Under-Sensing; Signal Artifact/Noise; Intermittent Capture; Fracture; High impedance; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE DELIVERED INAPPROPRIATE THERAPIES TO THE PATIENT AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED LEAD INTEGRITY ALERTS (LIAS) DUE TO HIGH RATE-NON-SUSTAINED EPISODES, OVERSENSING, NON-PHYSIOLOGIC/SENSING INTEGRITY COUNTER (SIC) WITH ONE THOUSAND TWO HUNDRED NINETY-NINE SHORT V-V INTERVALS, NOISE, UNDEFINED HIGH PACING IMPEDANCE, AND UNDERSENSING SAVED ON ELECTROGRAMS AND IN ADDITION, APPEARED TO RESULT IN INTERMITTENT CAPTURE DUE TO A LEAD FRACTURE. ON THE DAY OF EXTRACTION, IMAGING AND INTERROGATION OF THE DEVICE WERE PERFORMED AND INAPPROPRIATE SENSING IN BIPOLAR AND INTEGRATED BIPOLAR MODE COULD BE OBSERVED AND WITH ARM MOVEMENT SHOWED AN INCREASE OF OVERSENSING. THE CRT-D, RA LEAD, AND RV LEAD WERE SUBSEQUENTLY REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23006906 ↗
• InjuryDec 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) EXHIBITED A FRACTURE IN THE COIL OF THE HIGH VOLTAGE PORTION. 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 21034217 ↗
• MalfunctionJul 5, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING WHICH WAS SUSPECTED TO BE MYOPOTENTIAL OVERSENSING. THE LEAD REMAINS IN USE, AND THE CLINICIAN WILL CONTINUE TO MONITOR THE LEAD AT THIS TIME. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17258460 ↗
• InjuryApr 3, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS PRESENTING WITH T-WAVE OVERSENSING (TWOS) POST-VENTRICULAR PACE. REPROGRAMMING WAS PERFORMED UNTIL THE OVERSENSING WAS COVERED UP, 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 16663691 ↗
• InjuryAug 24, 2022Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD FAILED AND THAT IT HAD FRACTURED. IT WAS INDICATED THAT THE LEAD HAD BEEN L ASER-EXTRACTED AND THAT THERE WAS NO FURTHER INFORMATION AVAILABLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15284100 ↗
• MalfunctionMay 20, 2022Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD APPEARED TO EXHIBIT OCCASIONAL UNDERSENSING ON STORED EPISODES. 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 14453243 ↗
• InjuryFeb 4, 2022Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; High Capture Threshold; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). IN ADDITION, A LEAD NOISE WARNING TRIGGERED, AND OVERSENSING, HIGH PACING IMPEDANCE, AND HIGH THRESHOLDS WERE LATER OBSERVED. THE RIGHT VENTRICULAR (RV) LEAD WAS SUSPECTED FOR FRACTURE. THE LEAD WAS CUT, 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 13454049 ↗
• InjuryDec 2, 2021Signal Artifact/Noise; Fracture; Over-Sensing; Signal Artifact/Noise; Fracture; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE AND HIGH SENSING INTEGRITY COUNTER (SIC). THE LEAD WAS SUSPECTED TO BE FRACTURED AND 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 12916384 ↗
• InjuryJun 8, 2020Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE LEAD EXHIBITED NOISE AND ADDITIONAL OVERSENSING WAS RECORDED BY THE DEVICE AS NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT) EPISODES. THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10128019 ↗
• InjuryFeb 5, 2020Signal 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 PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO OVERSENSING OF NOISE, AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCES AND A POSSIBLE FRACTURE. THE LEAD WAS EXPLANTED AND REPLACED. DURING THE REPLACEMENT PROCEDURE, THE NEW RV LEAD WAS INITIALLY PLACED AND EXHIBITED A LOSS OF CAPTURE AT HIGH LEVELS AND HIGH IMPEDANCES. IT WAS SUSPECTED THAT THE LEAD HAD FRACTURED AS BLOOD WAS OBSERVED IN THE LUMEN, WHICH LED TO THE SEVERE PLACEMENT DIFFICULTY. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 9673564 ↗
• InjuryAug 26, 2019Fracture; High impedance; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem; Fracture; High impedance; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem

  IT WAS FURTHER REPORTED THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient; Shock from Patient Lead(s)

  MAUDE report 8933141 ↗
• InjuryApr 10, 2018Signal Artifact/Noise; Break; Fracture; Over-Sensing; Signal Artifact/Noise; Break; Fracture; Over-Sensing

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED FOR THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD EXHIBITED NOISE, ELEVATED SENSING INTEGRITY COUNTER (SIC), OVERSENSING, AND WAS POSSIBLY FRACTURED. THE LEAD WAS TURNED OFF AND LATER EXPLANTED AND REPLACED. DURING THE LEAD REPLACEMENT PROCEDURE, THE PHYSICIAN NOTICED BLOOD AND FLUID UNDERNEATH THE INSULATION OF THE LEAD . THE PHYSICIAN WAS UNABLE TO LOCATE WHERE THE INSULATION BREACH OCCURRED. 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 7414912 ↗
• MalfunctionApr 6, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE DURING IMPLANT OF THE RIGHT VENTRICULAR (RV) LEAD, THERE WAS DIFFICULTY PLACING THE LEAD DUE TO DIFFICULT PATIENT ANATOMY. AS A RESULT THE LEAD UNDERWENT A SIGNIFICANT AMOUNT OF PHYSICAL MANIPULATION AND WHEN THE LEAD WAS FINALLY POSITIONED IN AN IDEAL LOCATION, THE HELIX WOULD NOT EXTEND. THE LEAD WAS NOT USED AND THE CASE WAS ABANDONED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6467078 ↗