Attain Ability™ Plus MRI SureScan™ 429678 (UDI 00643169601789)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00643169601789), received between Dec 9, 2016 and Sep 10, 2026 — classified as 8 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026High impedance

  It was reported that the Left Ventricular (LV) lead exhibited high, out-of-range, undefined 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 50715093 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; High Capture Threshold; Unstable Capture Threshold; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; High Capture Threshold; Unstable Capture Threshold

  IT WAS FURTHER REPORTED THAT PER THE PHYSICIAN, THE LV LEAD HAD CHRONIC HIGH AND VARIABLE THRESHOLDS AND STIMULATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029622 ↗
• MalfunctionNov 4, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD PLUGGED INTO THE RIGHT VENTRICULAR (RV) LEAD PORT EXHIBITED INTERMITTENT UNDERSENSING. THE R WAVE HAD VARIABLE MEASUREMENTS. 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 20600535 ↗
• MalfunctionSep 22, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING THE REPLACEMENT PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD DID NOT PACE ONCE THE RIGHT VENTRICULAR (RV) LEAD WAS DISCONNECTED FROM THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P).  THE RV LEAD WAS IMMEDIATELY CONNECTED TO THE NEW DEVICE AND LV LEAD PACING RESUMED.  IT WAS NOTED THAT THE PATIENT WAS FINE, AND ALL TESTING WERE IN NORMAL LIMITS.  THE LV 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 17804002 ↗
• MalfunctionApr 20, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED CHRONIC HIGH THRESHOLDS. IT WAS ALSO NOTED THAT THE PATIENT WAS EXPERIENCING CHEST PAIN. THE LV LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FEATURE THAT MONITORS AND ADJUSTS LV LEAD THRESHOLDS TRIGGERED AN OBSERVATION WITH QUESTIONS MARKS INSTEAD OF A VOLTAGE READING. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 16777194 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. THE LV LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 12912329 ↗
• MalfunctionAug 11, 2021High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD INTERMITTENT UNDERSENSING AND THE LEFT VENTRICULAR (LV) LEAD HAD AN IMPEDANCE WARNING DUE TO HIGH AND UNDEFINED IMPEDANCE MEASUREMENT. IT WAS NOTED THAT THE PATIENT HAD GENERALIZED WEAKNESS. BOTH LEADS REMAIN 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 12307109 ↗
• InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM IS SCHEDULED TO BE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11357734 ↗
• InjuryApr 10, 2018Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED. IT WAS ALSO REPORTED THE LV LEAD EXHIBITED NO CAPTURE. THE LV LEAD WAS CAPPED 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 7414653 ↗
• InjuryAug 9, 2017Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD DISLODGED - AS CONFIRMED ON A CHEST X-RAY - AND THERE WAS NO CAPTURE, EVEN AT MAXIMUM OUTPUT. A LEAD REPOSITIONING WAS ATTEMPTED, HOWEVER THE TARGET BRANCH WAS NOT A STABLE LOCATION SO 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 6783083 ↗
• InjuryAug 9, 2017Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED DUE TO INFECTION. WHEN THE POCKET WAS OPENED, IT WAS DISCOVERED THAT THE LEFT VENTRICULAR (LV) LEAD HAD FRACTURED AND BROKEN INSULATION WAS OBSERVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 6780582 ↗
• MalfunctionApr 6, 2017Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED DURING THE IMPLANT PROCEDURE. THE LV LEAD WOULD NOT STAY IN PLACE AND KEPT SLIDING BACKWARDS IN THE VEIN DUE TO INSUFFICIENT FIXATION. 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 6468801 ↗
• MalfunctionApr 6, 2017Break; Break

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE LEFT VENTRICULAR LEAD DISTAL END WAS DAMAGED WHEN IT WAS PASSED THROUGH THE VALVE. 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 Known Impact Or Consequence To Patient

  MAUDE report 6467853 ↗
• InjuryFeb 9, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT VENTRICULAR (LV) LEAD DISLODGED DUE TO TWIDDLER'S SYNDROME. THE LV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Twiddlers Syndrome

  MAUDE report 6320616 ↗
• InjuryFeb 9, 2017High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD AT IMPLANT AS WELL AS POST-OPERATIVELY. THE LEAD WAS EXPLANTED AND REPLACED WITH AN EPICARDIAL LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6317211 ↗
• MalfunctionDec 9, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING ATTEMPTED IMPLANT THE LEFT VENTRICULAR (LV) LEAD DISLODGED MULTIPLE TIMES. A REPLACEMENT LV LEAD 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 6162676 ↗