Attain Ability™ MRI SureScan™ 419678 (UDI 00643169601765)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169601765), received between Feb 9, 2017 and May 14, 2026 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2026Extracardiac stimulation

  IT WAS REPORTED BY A PATIENT REPRESENTATIVE THAT THE PATIENT EXPERIENCED "ONE OF THEIR LEADS GOING AGAINST THEIR DIAPHRAGM" AND THAT THEY HAD TROUBLE SLEEPING. THEY REPORTED BEING IN THEIR DOCTOR'S OFFICE FOR ADJUSTMENTS TWICE. THE LEFT VENTRICULAR (LV) LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue; Sleep Dysfunction

  MAUDE report 25175896 ↗
• MalfunctionDec 16, 2025Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT OVERSENSING WAS NOTED ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR'S (CRT-D) ATRIAL CHANNEL DURING AN ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE DUE TO ELECTROMAGNETIC INTERFERENCE NOISE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL INCREASE IN CAPTURE THRESHOLDS AND PACING IMPEDANCE IN ADDITION TO MULTIPLE ALERTS FOR LOW PACING IMPEDANCE. THE RIGHT ATRIAL (RA) LEAD EXHIBITED AN INCREASE IN CAPTURE THRESHOLDS TO HIGH LEVELS. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED AN INCREASE IN CAPTURE THRESHOLDS. THE CRT-D AND 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 23816819 ↗
• MalfunctionNov 4, 2024Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS AND A LOSS OF CAPTURE. 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 20599506 ↗
• InjuryNov 8, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE LV 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 15754764 ↗
• InjurySep 18, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED FOR AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; No Consequences Or Impact To Patient

  MAUDE report 10552751 ↗
• InjuryMay 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED DUE TO A POCKET EROSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Wound Dehiscence

  MAUDE report 10039087 ↗
• InjuryAug 24, 2018Intermittent Capture; Capturing Problem; High Capture Threshold; Intermittent Capture; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH INCREASING THRESHOLDS. THE LEAD WAS PROGRAMMED OFF AND REMAIN IN THE PATIENT, OUT OF SERVICE. A NEW RV LEAD WAS IMPLANTED FROM THE RIGHT SIDE OF THE PATIENT. IT WAS FURTHER REPORTED THAT THE LV LEAD HAD HIGH INCREASING THRESHOLDS. THE LV LEAD WAS PROGRAMMED OFF AND WAS NOT REPLACED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 7812609 ↗
• MalfunctionJul 9, 2018Under-Sensing; High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. IT WAS ALSO REPORTED THE PATIENT'S RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING, DIMINISHED SENSING, AND HIGH THRESHOLDS. IT WAS FOUND THE RA LEAD HAD DISLODGED INTO THE SUPERIOR VENA CAVA (SVC), CAUSING THE DIAPHRAGMATIC STIMULATION. THE RA LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. THE RV LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THE PATIENT'S LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7670876 ↗
• InjuryOct 6, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF POST-OPERATIVE THUMPING. IT WAS DISCOVERED THAT THE PATIENT WAS EXPERIENCING PHRENIC NERVE STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS REPROGRAMMED TO RESOLVE THE STIMULATION AND REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE (B)(6) CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 6923517 ↗
• MalfunctionJun 8, 2017Activation, Positioning or Separation Problem; Appropriate Device Problem Term/Code Not Available; Activation, Positioning or Separation Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, A GUIDE WIRE COULD NOT PASS THROUGH THE LEFT VENTRICULAR (LV) LEAD. THE GUIDE WIRE RUPTURED IN THE LEAD AND NO SIGNAL COULD BE SEEN ON THE DEVICE WHEN THE ANALYZER CONNECTION WAS ESTABLISHED TO RECEIVE THE MEASUREMENT. THE LV LEAD WAS NOT USED 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 6628066 ↗
• MalfunctionFeb 9, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ATTEMPTED LEFT VENTRICULAR (LV) LEAD DISLODGED TWICE AFTER SHEATH SLITTING. THE LEAD WAS REMOVED AND A DIFFERENT LEAD TYPE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6320705 ↗