Attain Ability StraightRecalls & reported problems across all models
Medtronic, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 155
- Deaths reported
- 2
- Injuries reported
- 113
- Recalls
- 0
We found 2 models of Attain Ability Straight by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 155 adverse event reports in the FDA's MAUDE database, received between Jun 10, 2015 and Sep 16, 2026 — classified as 2 deaths, 113 injuries, 40 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (46 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Attain Ability Straight problems
Device problems
- Adverse Event Without Identified Device or Use Problem48
- High Capture Threshold46
- Failure to Capture19
- Capturing Problem17
- Device Dislodged or Dislocated11
- Appropriate Device Problem Term/Code Not Available10
- High impedance10
- Break7
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- No Known Impact Or Consequence To Patient35
- Unspecified Infection30
- Muscle Stimulation15
- Undesired Nerve Stimulation14
- Erosion6
- Device Overstimulation of Tissue5
- Pocket Erosion5
Attain Ability Straight models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Attain Ability® Straight 439688permanent pacemaker Electrode2 deaths129 reports
- Attain Ability® Straight 439678Drug eluting permanent left ventricular (lv) pacemaker electrode26 reports
Recent Attain Ability Straight adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026High 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 50785373 ↗InjuryMay 20, 2026Failure to Capture; High Capture Threshold
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE AND 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 25235982 ↗InjuryApr 29, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT STATED THAT DUE TO ISSUES WITH THE LEFT VENTRICULAR (LV) LEAD THE HOSPITAL INITIATED EXTERNAL CARDIAC PACING. THE PATIENT REPORTED FEELING "POUNDING" SINCE THE LV LEAD WAS IMPLANTED. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 25031820 ↗InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEADS WERE EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 25008087 ↗InjuryApr 23, 2026Break; Failure to Capture
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE AND SENSING INTEGRITY COUNTER (SIC). STORED EPISODES NOTED RV NOISE AND OVERSENSING RESULTING IN INHIBITION OF PACING AND MISCLASSIFICATION OF EPISODE TYPE. IT WAS NOTED THAT ¿IT APPEARED AS THOUGH A WIRE ISN'T CONNECTED¿. IT WAS FURTHER NOTED THAT A LOW VOLTAGE RV LEAD FRACTURE WAS SUSPECTED. THE RV LEAD WAS EXPLANTED AND REPLACED. DURING THE REPLACEMENT PROCEDURE, IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS ¿NOT RELIABLE AND DID NOT TEST WELL¿. IT WAS NOTED THAT THE LV LEAD ¿STOPPED WORKING AND DISINTEGRATED¿ WHEN THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS PULLED OUT OF THE POCKET. WHEN TESTED THROUGH CABLES, THE LV LEAD HAD NO CAPTURE. 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 24971089 ↗InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POCKET HAD WOUND DEHISCENCE AND WAS OOZING WITH PUS. THE PATIENT EXPERIENCED INFECTION, DISCOMFORT, EROSION, REDNESS AND SWELLING. THE CRT-D SYSTEM WAS EXPLANTED AND REPLACED WITH A TEMPORARY EXTERNAL IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM SO THE PATIENT COULD RECOVER FROM THE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Discomfort; Erythema; Medical device site infection; Pocket Erosion; Purulent Discharge; Wound Dehiscence
MAUDE report 24841831 ↗InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POCKET HAD WOUND DEHISCENCE AND WAS OOZING WITH PUS. THE PATIENT EXPERIENCED INFECTION, DISCOMFORT, EROSION, REDNESS AND SWELLING. THE CRT-D SYSTEM WAS EXPLANTED AND REPLACED WITH A TEMPORARY EXTERNAL IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM SO THE PATIENT COULD RECOVER FROM THE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Discomfort; Erythema; Medical device site infection; Pocket Erosion; Purulent Discharge; Wound Dehiscence
MAUDE report 24841830 ↗MalfunctionFeb 26, 2026Failure to Capture
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CONGESTIVE HEART FAILURE. BIVENTRICULAR CAPTURE COULD NOT BE CONFIRMED VIA DEVICE IN TERROGATION. THE RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Heart Failure/Congestive Heart Failure
MAUDE report 24453605 ↗MalfunctionFeb 17, 2026High Capture Threshold
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH/UNDEFINED IMPEDANCE. THE LV LEAD AND RA LEAD 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 24369179 ↗MalfunctionNov 25, 2025High Capture Threshold; High Capture Threshold
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD THRESHOLD WAS GREATER THAN THE PROGRAMMED AMPLITUDE. 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 23652872 ↗MalfunctionOct 20, 2025Failure to Capture; Failure to Capture
IT WAS REPORTED THAT SUSPECTED LOSS OF CAPTURE ON THE LEFT VENTRICULAR (LV) LEAD OCCURRED. 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 23335371 ↗MalfunctionSep 19, 2025Capturing Problem; Capturing Problem
IT WAS REPORTED THAT THERE WAS AN INCREASE IN LEFT VENTRICULAR (LV) LEAD THRESHOLD MEASUREMENTS NOTED ON LEAD TRENDS. IT WAS ALSO NOTED THAT THE PATIENT WAS RECENTLY IN THE INTENSIVE CARE UNIT (ICU) DUE TO A DEVICE MALFUNCTION. THE LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 23102889 ↗MalfunctionSep 4, 2025Electrical /Electronic Property Problem; Low impedance; Electrical /Electronic Property Problem; Low impedance
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT OUT OF RANGE (OOR) LOW IMPEDANCE WITH POLARITY SWITCH TRIGGERED WHILE THE PATIENT WAS IN THE HOSPITAL WITH INCREASED FLUID. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22962301 ↗MalfunctionJul 17, 2025Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold
IT WAS REPORTED THAT THE TELEMETRY NURSE OBSERVED POSSIBLE LOSS OF CAPTURE. NO PARTICULAR LEAD OR NUMBER OF LEADS WAS SPECIFIED. IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. THE RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA), AND LV 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 22531388 ↗MalfunctionJul 10, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED BY THE PATIENT THAT THEIR LEFT VENTRICULAR (LV) LEAD WAS NOT MAKING A GOOD CONNECTION AND WAS DRAINING THE BATTERY OF THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE. THE LV LEAD AND CRT-D 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 22474714 ↗
Other Medtronic, Inc. products
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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