Attain Ability™ Straight MRI SureScan™ 439688 (UDI 00643169601819)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00643169601819), received between Dec 9, 2016 and Nov 10, 2025 — classified as 13 injuries, 10 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (11 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2025Failure to Capture; Over-Sensing; Impedance Problem; High Capture Threshold; Failure to Capture; Over-Sensing; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT LEAD PLACED IN THE ANTERIOR CARDIAC VEIN AND PLUGGED INTO THE RIGHT VENTRICULAR (RV) LEAD PACE SENSE PORTION OF THE DEVICE HEADER EXHIBITED A LOSS OF CAPTURE, A RISE IN PACING IMPEDANCE, ELEVATED THRESHOLDS AND OVERSENSING NOTED ON THE CURRENT ELECTROGRAM (EGM). THE LEAD WAS REPROGRAMMED AND 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 23512496 ↗
• MalfunctionAug 27, 2024Failure to Capture; High impedance; Low impedance; Adverse Event Without Identified Device or Use Problem; High Capture Threshold; Failure to Capture; High impedance; Low impedance; Adverse Event Without Identified Device or Use Problem; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED AN WARNING FOR HIGH UNDEFINED IMPEDANCE. THE LV EXHIBITED POSSIBLE LOSS OF CAPTURE AND THE THRESHOLDS WERE HIGHER THAN THE PROGRAMMED OUTPUT. IT WAS NOTED THAT THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION FROM THE LV LEAD IN SOME PACING VECTORS. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 20079374 ↗
• MalfunctionAug 12, 2024Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS FURTHER REPORTED THAT THE PATIENT HAD A DEVICE CHECK CHECK/OFFICE VISIT. NO ACTION/INTERVENTION WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19964684 ↗
• MalfunctionJan 9, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. 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 18474164 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STATED GOT "STAPH INFECTION AND IT GOT INTO THE BLOOD STREAM".  THE PATIENT INDICATED ALREADY WORKING WITH THE PHYSICIAN.  THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 18056074 ↗
• MalfunctionJun 2, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE PATIENT COMPLAINED OF CONSTANT SHORTNESS OF BREATH (SOB) AND BECAUSE OF THE SOB ALLEGED THAT THE DEVICE IS DEFECTIVE. THE PATIENT DOES NOT ALLOW ANY TESTING ON THE CRT-D.  IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD ENCOUNTERED HIGH THRESHOLDS.  THE RV LEAD WAS NOTED WITH POSSIBLE UNDERSENSING.  ADDITIONALLY, IT WAS REPORTED THAT THE LV LEAD IS IN THE RV PACE/SENSE PORT AND THE RV LEAD PACE/SENSE IS IN THE LV PORT. THE CRT-D, RV LEAD AND LV LEAD 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 14574443 ↗
• MalfunctionMar 31, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT AN ALERT TRIGGERED FOR OUT-OF-RANGE PACING IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. HIGH PACING THRESHOLDS WERE NOTED ON THE LEFT VENTRICULAR (LV) LEAD. UNDERSENSING WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE 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 13963248 ↗
• InjurySep 23, 2020Break; Break

  IT WAS FURTHER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED NOISE ON THE ATRIAL CHANNEL DUE TO CAUTERY DURING THE RV LEAD REVISION. THE CRT-P REMAINS IN USE.

  Patient problems: Occlusion

  MAUDE report 10577081 ↗
• MalfunctionOct 16, 2019High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE RA LEAD AND THE LV LEAD REMAIN 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 9199048 ↗
• InjuryJul 3, 2019Failure to Capture; Capturing Problem; Adverse Event Without Identified Device or Use Problem; High Capture Threshold; Failure to Capture; Capturing Problem; Adverse Event Without Identified Device or Use Problem; High Capture Threshold

  ADDITIONAL INFORMATION RECEIVED INDICATED THE LV LEAD WAS CAPPED, AND PLACEMENT OF TWO NEW COMPETITOR EPICARDIAL LV LEADS WAS PERFORMED. APPROXIMATELY SIXTEEN MONTHS LATER, DURING A COMPETITOR LEADS REVISION PROCEDURE, AT THE SITE OF THE CAPPED LV LEAD, AN OLD FULL INFECTION WAS NOTED. GIVEN THE SIGNS OF FULL INFECTION, ANTIBIOTIC MEDICATION WAS ADMINISTERED. THE POCKET WAS IRRIGATED WITH SALINE SOLUTION, AND THE CAP CLEANED AND REPLACED.

  Patient problems: Cardiomyopathy; Dyspnea; Edema; Heart Failure; Muscle Stimulation; Pulmonary Edema; Swelling; Unspecified Infection

  MAUDE report 8761236 ↗
• InjuryApr 17, 2019High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT HIGH LEFT VENTRICULAR (LV) LEAD THRESHOLD LEAD TO PREMATURE BATTERY DEPLETION ON THE IMPLANTABLE PULSE GENERATOR (IPG). THE LV LEAD WAS CAPPED AND REPLACED. THE 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 8524160 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED APPROXIMATELY SIX WEEKS POST IMPLANT DUE TO POCKET NECROSIS. IT WAS FURTHER REPORTED THAT PRIOR TO DEVICE SYSTEM IMPLANT THE PATIENT HAD RECEIVED RADIATION TO THEIR UPPER CHEST. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Necrosis

  MAUDE report 8237850 ↗
• MalfunctionAug 30, 2018High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT AN LEFT VENTRICULAR (LV) LEAD, THAT WAS PLUGGED INTO THE RIGHT VENTRICULAR (RV) LEAD PORT, EXHIBITED HIGH THRESHOLD. THE LEAD 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 7834526 ↗
• MalfunctionApr 25, 2018Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS OBSERVED WITH RISING AND HIGH THRESHOLD. THE LEAD 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 7462185 ↗
• InjuryApr 24, 2018Intermittent Capture; Intermittent Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS CAPTURING INTERMITTENTLY WHEN THE PATIENT PRESENTED TO THE CLINIC. REPROGRAMMING WAS DONE, AND THE LEAD 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 7457009 ↗
• InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED DUE TO ENDOCARDITIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis

  MAUDE report 7418364 ↗
• InjuryApr 10, 2018Adverse 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 AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7416206 ↗
• InjuryAug 9, 2017Appropriate Device Problem Term/Code Not Available; High Capture Threshold; Appropriate Device Problem Term/Code Not Available; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH DIAPHRAGMATIC STIMULATION. A DEVICE CHECK REVEALED THE LEFT VENTRICULAR (LV) LEAD EXPERIENCED A HIGH THRESHOLD LEVELS. IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXPERIENCED INTERMITTENT ATRIAL UNDERSENSING. THE PATIENT WAS ADMITTED TO THE HOSPITAL. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE LEFT VENTRICULAR (LV) LEAD AND RIGHT ATRIAL (RA) LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Stimulation

  MAUDE report 6780210 ↗
• InjuryJun 8, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Muscle Stimulation; Undesired Nerve Stimulation

  MAUDE report 6627009 ↗
• InjuryJun 8, 2017Capturing Problem; Positioning Problem; Appropriate Device Problem Term/Code Not Available; Capturing Problem; Positioning Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD AND IT WAS NOTED THE LV LEAD HAD MIGRATED WITH AN INCREASE IN PACING THRESHOLD VALUES. THE LV LEAD WAS INACTIVATED AND LATER EXPLANTED AND REPLACED. THE PATIENT IS A PARTICIPANT IN THE ADAPT RESPONSE CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 6625887 ↗
• MalfunctionFeb 9, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE GUIDEWIRE KEPT GETTING CAUGHT INSIDE THE LEAD AND COULD NOT BE ADVANCED. THE LEAD WAS NOT USED AND A NEW 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 6321068 ↗
• MalfunctionFeb 9, 2017Break; Break

  IT WAS REPORTED THAT DURING A LEAD REVISION PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD WAS INADVERTENTLY CUT WHEN THE PHYSICIAN WAS CUTTING THE SUTURE AFTER ANCHORING THE LEAD IN THE POCKET. 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 6320341 ↗
• InjuryDec 9, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED. THE LV 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 6163756 ↗