Sprint Quattro Secure S® 6935M72 (UDI 00613994718877)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00613994718877), received between Apr 10, 2018 and Jul 16, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Over-Sensing” (5 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 16, 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2025Failure to Capture; Fracture; High impedance; Over-Sensing; Failure to Capture; Fracture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY WHILE SWIMMING IN A POOL. A REVIEW OF THE EPISODE BY QUALIFIED PERSONNEL DETERMINED THAT THERE WAS INHIBITION OF PACING RELATED TO OVERSENSING OF ELECTROMAGNETIC INTERFERENCE (EMI). THERE WAS A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO HIGH RATE NON-SUSTAINED (HRNS) EPISODES AND SENSING INTEGRITY COUNTER (SIC). IT WAS FURTHER REPORTED THAT A LOSS OF CAPTURE WAS SUSPECTED ON THE RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS AFTER THE SHOCK WAS DELIVERED. THERE WAS UNDEFINED HIGH RV PACING IMPEDANCE, T-WAVE OVERSENSING (TWOS), AND A KNOWN RV TIP ELECTRODE FRACTURE. THE LEADS WERE REPROGRAMMED AND REMAIN IN USE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522180 ↗
• InjurySep 1, 2023Decreased Sensitivity; High Capture Threshold; Decreased Sensitivity; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED SMALL R-WAVES IN THE BIPOLAR CONFIGURATION. IN ADDITION, THERE WERE HIGH RV THRESHOLDS CAUSING THE RV CAPTURE MANAGEMENT TO ABORT. IN-OFFICE TESTING DID NOT REVEAL ANY HIGH THRESHOLDS AND THE PATIENT WAS TESTED IN THE SITTING POSITION. THE RV LEAD WAS REPROGRAMMED FROM BIPOLAR TO TIP TO COIL, 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 17673617 ↗
• InjuryNov 8, 2021Adverse 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12771204 ↗
• InjuryOct 7, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCE SYNCOPE THE DEVICE WAS CHECKED AND IT WAS FOUND THAT THE RV LEAD HAD INTERMITTENT OVERSENSING. THE DEVICE WAS CHECKED AGAIN THE FOLLOWING DAY AND T-WAVE OVERSENSING (TWOS) ON THE CURRENT ELECTROGRAMS (EGM) WAS FOUND. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 12590516 ↗
• InjuryJul 14, 2021High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING/HIGH IMPEDANCES. 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 12166325 ↗
• InjuryNov 3, 2020Over-Sensing; Pacing Problem; Impedance Problem; Over-Sensing; Pacing Problem; 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 IMPEDANCE VARIATION. THE RV LEAD ALSO HAD OVERSENSING AND INHIBITED PACING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10782379 ↗
• InjuryMar 30, 2020Fracture; High impedance; Inappropriate/Inadequate Shock/Stimulation; Fracture; High impedance; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD FRACTURED AND THE PATIENT RECEIVED INAPPROPRIATE THERAPY. 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 9897408 ↗
• InjuryNov 7, 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 INFECTION AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9292481 ↗
• InjuryDec 11, 2018Over-Sensing; Pacing Problem; Decreased Sensitivity; Over-Sensing; Pacing Problem; Decreased Sensitivity

  IT WAS REPORTED THAT AN IN-OFFICE CHECK FOUND THAT THE RIGHT VENTRICULAR (RV) LEAD HAD VERY SMALL R-WAVES. THERE HAD ALSO BEEN SIGNIFICANT EPISODES OF T-WAVE OVERSENSING (TWOS) EARLIER IN THE MONTH OF WHICH THE T-WAVE DISCRIMINATION FEATURE APPLIED AND KEPT THE PATIENT FROM GETTING INAPPROPRIATE SHOCKS. IT WAS NOTED THAT DUE TO THE T-WAVE OVERSENSING POST VS (VENTRICULAR SENSED) THERE WAS A LOSS OF CRT (CARDIAC RESYNCHRONIZATION THERAPY) PACING. THE RV LEAD WAS REPROGRAMMED AND 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 8153473 ↗
• InjuryJul 25, 2018Under-Sensing

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD UNDERSENSED THE PATIENT'S VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF). THE RV LEAD WAS CAPPED AND A NEW RV LEAD AND SUBCUTANEOUS COIL WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Failure of Implant; Ventricular Fibrillation; Ventricular Tachycardia

  MAUDE report 7719088 ↗
• InjuryApr 10, 2018Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD T-WAVE OVERSENSING (TWOS) POST BI-VENTRICULAR PACING. THE LEAD WAS REPROGRAMMED AND 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 7415568 ↗