Attain Ability™ MRI SureScan™ 419678 (UDI 00643169860025)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169860025), received between Apr 24, 2018 and Nov 12, 2024 — classified as 14 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2024Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED AN INCREASE TO HIGH THRESHOLD 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 20669639 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SIGNIFICANT BRUISING FROM THE PROCEDURAL TABLE WITH ONGOING DISCOMFORT AT THE CARDIAC RESYNCHRO NIZATION THERAPY PACEMAKER (CRT-P) SITE. IT WAS FURTHER NOTED THAT THE PATIENT SUBSEQUENTLY EXPERIENCED LEFT ARM AND LEFT BREAST EDEMA AND AT A LEFT VENTRICULAR (LV) LEAD CHANGE OUT PROCEDURE, IT WAS NOTED THAT A LEFT EXTREMITY VENOGRAPHY REVEALED THERE WAS SIGNIFICANT VENOUS STENOSIS/OCCLUSION WITH EXTENSIVE COLLATERALS OF THE SUBCLAVIAN VENOUS SYSTEM WITH MORE AT THE SUBCLAVIAN AXILLARY VEIN. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. THE CRT-P, RIGHT ATRIAL (RA) LEAD, AND RIGHT VENTRICULAR (RV) LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Obstruction/Occlusion; Stenosis; Swelling/ Edema

  MAUDE report 20622865 ↗
• InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD POST-OPERATIVELY DISLODGED. THE 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 19118197 ↗
• InjuryApr 3, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD NO SENSING IN BIPOLAR CONFIGURATION. NO CAPTURE WAS NOTED ON THE LEFT VENTRICULAR (LV) LEAD LEAD. THE RV LEAD WAS REPROGRAMMED, EXPLANTED AND REPLACED. THE LV 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 19030313 ↗
• InjuryAug 2, 2023High 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 CO MPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442987 ↗
• MalfunctionDec 9, 2022Low impedance; Low impedance

  IT WAS REPORTED THAT AN ALERT TRIGGERED FOR LOW IMPEDANCE ON THE LEFT VENTRICULAR (LV) LEAD. 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 15948989 ↗
• InjuryDec 3, 2021Failure to Capture; High impedance; High Capture Threshold; Failure to Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE WHEN THE LEFT VENTRICULAR (LV) LEAD WAS CONNECTED TO THE DEVICE THERE WAS A SUDDEN INCREASE IN IMPEDANCE AND THRESHOLD. IT WAS NOTED THE LEAD EXHIBITED HIGH IMPEDANCE, HIGH THRESHOLDS, AND NO CAPTURE. THE LEAD WAS REMOVED FROM THE HEADER AND REINSERTED THREE TIMES BUT THE ISSUE PERSISTED. THE LEAD WAS PROGRAMMED TO AN INACTIVE STATUS AND REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12927348 ↗
• MalfunctionNov 18, 2021Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE LEFT VENTRICULAR (LV) LEAD WAS UNABLE TO CAPTURE EVEN AT HIGH OUTPUTS IN A LOCATION WHERE NORMAL CAPTURE WAS EXPECTED. IT WAS ALSO NOTED THAT THE CURRENT SEEMED HIGH FOR THE LEAD. UPON TESTING THE LEAD THERE WAS A SYSTEM ERROR FOR A BROKEN CIRCUIT. THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12839842 ↗
• InjuryApr 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED. THE 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 11749352 ↗
• InjuryNov 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN BRADYCARDIA AND ABNORMAL CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) FUNCTION WAS SUSPECTED. IT WAS CONFIRMED THAT THE LEFT VENTRICULAR (LV) LEAD HAD MOVED OUT OF THE CORONARY SINUS BRANCH IN WHICH IT WAS IN. THE LEAD WAS REMOVED AND REPLACED WITH A HIS BUNDLE PACING LEAD. THE CRT-P REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 10909880 ↗
• InjuryMar 21, 2020Device Dislodged or Dislocated; High Capture Threshold; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT ONE DAY POST IMPLANT THE RIGHT ATRIAL (RA) LEAD DISLODGED AND WAS SENSING AND PACING IN THE RIGHT VENTRICULAR. IT WAS ADDITIONALLY NOTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND WAS SUSPECTED TO HAVE DISLODGED. LEAD REVISIONS WERE PLANNED FOR LATER THAT DAY AND THE LEADS 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 9863353 ↗
• InjuryFeb 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A POCKET INFECTION OCCURRED. IT WAS ALSO REPORTED THERE WAS SUSPECTED VEGETATION ON THE SYSTEM LEADS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9723106 ↗
• InjuryOct 16, 2019Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED POST OPERATIVELY AND ATTEMPTS TO REPOSITION THE LEAD WERE UNSUCCESSFUL. PLACEMENT DIFFICULTY WAS NOTED AS THE PHYSICIAN WAS UNABLE TO GET THE LEAD INTO THE TARGET VESSEL. THE LEAD WAS EXPLANTED AND WILL BE REPLACED IN THE FUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9199960 ↗
• InjuryJul 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD DISLODGED. 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 8808450 ↗
• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS REMOVED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8638856 ↗
• InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIAPHRAGMATIC STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS REPROG RAMMED AND REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE ADAPTRESPONSE CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Stimulation

  MAUDE report 8333114 ↗
• InjuryApr 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION. THE PATIENT'S LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 7456011 ↗