Attain Performa™ Straight MRI SureScan™ 439888Recalls & reported problems
Medtronic, Inc. · LEAD 439888 MRI STRAIGHT US · Class 3 · Implant
All models of Attain Performa Straight MRI SureScan (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic Attain Performa Straight MRI SureScan is a left ventricular pacing lead, a wire placed in the heart to help it beat. Its 1,576 reports describe many cases of the lead failing to reliably trigger heartbeats, and others mention pocket infections, dislodged leads or nerve stimulation. The reports mention 26 deaths and 1,068 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,595
- Deaths reported
- 26
- Injuries reported
- 1,078
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,595 adverse event reports that list this exact device (DI 00643169601857), received between Dec 9, 2016 and Sep 30, 2026 — classified as 26 deaths, 1,078 injuries, 491 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (393 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem668
- High Capture Threshold393
- Failure to Capture195
- Capturing Problem174
- Device Dislodged or Dislocated133
- High impedance77
- Appropriate Device Problem Term/Code Not Available63
- Activation, Positioning or Separation Problem61
Patient problems
- No Clinical Signs, Symptoms or Conditions545
- Unspecified Infection352
- No Known Impact Or Consequence To Patient181
- Undesired Nerve Stimulation120
- Device Overstimulation of Tissue113
- Muscle Stimulation67
- No Consequences Or Impact To Patient32
- Sepsis32
Recent adverse event reports
The 25 most recent of 1,595 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952438 ↗InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936943 ↗MalfunctionSep 25, 2026Capturing Problem
It was reported that the Left Ventricular (LV) lead and Right Ventricular (RV) lead exhibited rising pacing thresholds. The leads re main in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899304 ↗MalfunctionSep 25, 2026Capturing Problem
It was reported that the Left Ventricular (LV) lead exhibited rising thresholds. 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 50897441 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that approximately one month post replacement procedure, the patient developed a pocket infection. It was noted that the patient developed purulent discharge/pus. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted and replaced with a Leadless Implantable Pulse Generator (IPG). No further patient complications have been reported as a result of this event.
Patient problems: Unspecified Infection
MAUDE report 50877091 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced bacteremia. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) and leads were explanted and replaced with a leadless Implantable Pulse Generator (IPG). No further patient complications have been reported as a result of this event.
Patient problems: Bacteremia
MAUDE report 50868656 ↗InjurySep 22, 2026Extracardiac stimulation
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50859213 ↗InjurySep 18, 2026Fracture; Capturing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829309 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50827665 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50811601 ↗MalfunctionSep 17, 2026Low impedance
It was reported that the Left Ventricular (LV) lead exhibited low pacing 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 50803840 ↗MalfunctionSep 15, 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 had position check failure. Both LV and RA 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 50766879 ↗MalfunctionSep 14, 2026Impedance Problem
It was reported that the Right Ventricular (RV) lead exhibited an increase in pacing impedance and possible loss of capture, and the Left Ventricular (LV) lead exhibited an increase in pacing impedance. 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 50754905 ↗MalfunctionSep 10, 2026Intermittent Capture; Pacing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721374 ↗MalfunctionSep 8, 2026High impedance; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50680306 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Medical device site infection
MAUDE report 50679306 ↗InjurySep 8, 2026Extracardiac stimulation
Patient problems: Device Overstimulation of Tissue
MAUDE report 50679157 ↗MalfunctionSep 4, 2026Electrical /Electronic Property Problem; Impedance Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50613766 ↗InjurySep 3, 2026Extracardiac stimulation
It was reported by the patient that their Cardiac Resynchronization Therapy Pacemaker (CRT-P) has ¿faster than expected battery depletion¿ and they are experiencing dizziness and lightheadedness. Additionally, the patient noted that they previously had diaphragmatic stimulation and adjustments were made. The patient inquired if the adjustments may have affected their CRT-P and health. The CRT-P and Left Ventricular (LV) lead remain in use. No further patient complications have been reported as a result of this event.
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50590506 ↗InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed a pocket infection approximately one month post-Cardiac Resynchronization Therapy Defibri llator (CRT-D) implant. The patient had also experienced purulent discharge/pus, redness and swelling. The organism was identified as Staphylococcus aureus. The CRT-D system was removed and a leadless pacemaker was implanted. No further patient complications have been reported as a result of this event.
Patient problems: Bacterial Infection; Erythema; Medical device site infection; Purulent Discharge; Swelling/ Edema
MAUDE report 50530530 ↗MalfunctionAug 31, 2026High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518627 ↗InjuryAug 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Erosion; Unspecified Infection
MAUDE report 50513032 ↗InjuryAug 25, 2026Extracardiac stimulation
It was reported that the patient was experiencing phrenic nerve stimulation from the Left Ventricular (LV) lead. The lead was explanted and replaced. No further patient complications have been reported as a result of this event.
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50440709 ↗InjuryAug 24, 2026Failure to Capture
It was reported that the patient experienced syncope, a fall and was in a car accident. It was further reported that the Cardiac Res ynchronization Therapy Pacemaker (CRT-P) exhibited a pacing issue, the Right Ventricular (RV) lead exhibited high thresholds and intermittent capture and that the Left Ventricular (LV) lead exhibited no capture. The CRTP system remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Fall; Syncope/Fainting
MAUDE report 50409273 ↗InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced a pocket infection that presented with discomfort, redness, and purulent discharge/pus. The Cardiac Resynchronization Therapy Pacemaker (CRT-P) system was explanted and a leadless pacemaker was implanted. No further patient complications have been reported as a result of this event.
Patient problems: Discomfort; Erythema; Medical device site infection; Purulent Discharge
MAUDE report 50308399 ↗
Other Drug eluting permanent left ventricular (lv) pacemaker electrode devices
- Attain Stability™ Quad MRI SureScan™ 479888Medtronic, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode28 deaths2,213 reports
- Sentus ProMRI OTW QP L-85/49 408719BIOTRONIK SE & Co. KG · Drug eluting permanent left ventricular (lv) pacemaker electrode7 deaths1,385 reports
- Quartet™ 1457Q-86St. Jude Medical, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode21 deaths1,061 reports
- Quickflex™ 1258TSt. Jude Medical, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode26 deaths996 reports
- ATTAIN® BIPOLAR OTW 419488Medtronic, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode15 deaths730 reports
- Attain Ability® Plus 429688Medtronic, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode11 deaths529 reports
- Sentus ProMRI OTW QP S-85/49 406082BIOTRONIK SE & Co. KG · Drug eluting permanent left ventricular (lv) pacemaker electrode1 death511 reports
- ATTAIN® BIPOLAR OTW 419478Medtronic, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode5 deaths464 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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