Attain Ability™ Plus MRI SureScan™ 429678 (UDI 00643169860124)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169860124), received between Dec 7, 2017 and Jun 12, 2025 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. IT WAS NOTED THAT CULTURES WERE TAKEN BUT YIELD NO GROWTH. THE CARDIAC RE SYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22197796 ↗
• MalfunctionSep 6, 2024Low impedance; Low impedance

  IT WAS REPORTED THAT A WARNING TRIGGERED FOR LOW PACING IMPEDANCE ON THE LEFT VENTRICULAR (LV) LEAD. IT WAS NOTED THAT THE LEAD IMPEDANCE MEASUREMENT CHRONICALLY RAN ON THE LOW SIDE AND THE LEAD TREND WAS STABLE. 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 20158157 ↗
• InjuryNov 9, 2023Adverse 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 CAUSED BY THE LEFT VENTRICULAR (LV) LEAD. IT WAS NOTED THAT THE CLINICIAN/PATIENT REPORTED BODY MOVEMENT ON THE PATIENT. IT WAS NOTED THAT THE PATIENT BODY WAS TWITCHING. REPROGRAMMED WAS DONE, WHICH RESOLVED THE STIMULATION, AND THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Twitching; Undesired Nerve Stimulation

  MAUDE report 18098253 ↗
• MalfunctionMar 3, 2022Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INTERMITTENT UNDERSENSING. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED AN IMPEDANCE WARNING AND OVERSENSING WAS NOTED ON CURRENT ELECTROGRAMS. BOTH 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 13664661 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; High Capture Threshold; Adverse Event Without Identified Device or Use Problem; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND STIMULATION AT HIGH OUTPUTS. THE LV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 12830867 ↗
• InjuryAug 5, 2021Failure to Capture; Adverse Event Without Identified Device or Use Problem; Failure to Capture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXTRA STIMULATION FROM A NEWLY PLACED RIGHT VENTRICULAR (RV) LEAD. THE PATIENT STATED THAT WHEN LAYING DOWN ON THEIR LEFT SIDE "IT FELT LIKE A BABY WAS KICKING" AND THAT THEY HAD BEEN BACK TO THE CLINIC TWICE AND THEY NO LONGER FEEL IT. THE PATIENT FURTHER REPORTS THAT EVERY NIGHT AT THE SAME TIME THEY FEEL THAT SAME SENSATION WHICH WAS ATTRIBUTED TO THE PROGRAM THAT MONITORS PACING THRESHOLDS AT DIFFERENT INTERVALS. ADDITIONALLY, THE CLINIC DISCLOSED THAT THE PATIENT EXHIBITED PHRENIC STIMULATION WHICH THE PATIENT COULD NOT TOLERATE. LOSS OF CAPTURE WAS NOTED SEVERAL TIME. THE PROGRAMMED FEATURE THAT MONITORS PACING THRESHOLDS AT DIFFERENT INTERVALS WAS TURNED OFF AND OUTPUTS WERE DECREASED. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 12284945 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELT THEIR HEARTBEAT IN THEIR BELLY. IT WAS NOTED THE PATIENT WAS EXPERIENCING DIAPHRAGMATIC 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: Muscle Stimulation

  MAUDE report 10256154 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS POST IMPLANT AN INFECTION OCCURRED. THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED AND LATER REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9921076 ↗
• InjuryJun 28, 2019Failure to Capture; Impedance Problem; Failure to Capture; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE ON SEVERAL CONSECUTIVE BEATS. IT WAS NOTED THAT THERE WAS VARYING IMPEDANCE VALUES BETWEEN BIPOLAR AND UNIPOLAR. THE RV 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 8743534 ↗
• MalfunctionJun 11, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE GUIDEWIRE COULD NOT BE ADVANCED PAST THE TIP OF THE LEAD. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8689239 ↗
• InjuryOct 17, 2018Break; Break

  IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD WAS "BROKEN." IT 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 7974942 ↗
• InjuryApr 25, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS DISLODGED. BOTH WERE TO BE REPOSITIONED, HOWEVER THE RV LEAD HELIX COULD NOT BE RETRACTED AND UPON REMOVING THE LEAD FROM THE PATIENT, THERE WAS TISSUE IN THE LEAD TIP. THE LV LEAD WAS DROPPED FROM THE STERILE FIELD. THE LEAD WERE NOT RE-USED AND NEW LEADS WERE IMPLANTED. WHEN THE PHYSICIAN CONNECTED THE NEW RV LEAD TO THE CHRONIC DEVICE, THE HIGH VOLTAGE IMPEDANCE MEASURED HIGH. IT WAS RE-INSERTED INTO THE DEVICE HEADER WITH THE SAME RESULT AND WHEN THE LEAD TESTED WITHIN NORMAL LIMITS THROUGH THE LEAD ANALYZER, THE PHYSICIAN REQUESTED A NEW DEVICE. THE CHRONIC DEVICE 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 7462746 ↗
• InjuryDec 7, 2017Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT LOSS OF LEFT VENTRICULAR (LV) LEAD CAPTURE WAS NOTED DURING A FOLLOW-UP CHECK AND IT WAS NOTED THE LV LEAD HAD DISLODGED AND PULLED BACK INTO THE CORONARY SINUS (CS). THE LV LEAD WOULD NOT CAPTURE AT MAX OUTPUT AND EXHIBITED A HIGH PACING THRESHOLD. THE LV LEAD WAS REPOSITIONED INTO A BRANCH OF THE CS 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 7092084 ↗