Myopore® Sutureless Myocardial Pacing Lead 511212Recalls & reported problems
Greatbatch Ltd · Myopore® Bipolar Sutureless Pacing Lead · Class 3 · Implant
All models of Myopore Sutureless Myocardial Pacing Lead (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Greatbatch Myopore sutureless pacing lead is a wire attached to the heart muscle to help it beat. Of its 273 reports, 143 are injury reports, 127 are malfunction reports, and 2 deaths are listed. Many describe infections around the lead, often leading to its removal, and some describe the lead failing to pace the heart. 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
- 274
- Deaths reported
- 2
- Injuries reported
- 144
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 274 adverse event reports that list this exact device (DI 00821329900228), received between Aug 11, 2015 and Sep 18, 2026 — classified as 2 deaths, 144 injuries, 127 malfunctions.
The most frequently reported specific device problem is “Failure to Capture” (56 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 Problem147
- Failure to Capture56
- High Capture Threshold42
- High impedance12
- Device Dislodged or Dislocated9
- Insufficient Device Problem Information9
- Fracture8
- Low impedance6
Patient problems
- Unspecified Infection107
- No Clinical Signs, Symptoms or Conditions71
- Therapeutic Response, Decreased36
- Bacterial Infection12
- Sepsis11
- No Known Impact Or Consequence To Patient8
- Erosion6
- No Information6
Recent adverse event reports
The 25 most recent of 274 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
InjuryAug 21, 2026Failure to Capture; Fracture; Device Sensing Problem; Impedance Problem
Failure of epicardial left ventricular lead was reported. Required urgent implant of new leadless pacemaker. Conductor fracture, impedance change with significant sensing and capture issues were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50378511 ↗InjuryAug 3, 2026High Capture Threshold
High thresholds on epicardial left ventricle lead was reported. Lead was capped. This event is related to 2183787-2026-00050.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50123125 ↗InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem
LEAD WAS INFECTED. LEAD WAS IMPLANTED, OUT-OF-SERVICE. THIS EVENT IS RELATED TO 2183787-2026-00045.
Patient problems: Unspecified Infection
MAUDE report 25660886 ↗InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS IMPLANTABLE LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD WAS SURGICALLY ABANDONED.
Patient problems: Unspecified Infection
MAUDE report 25405634 ↗InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS IMPLANTABLE LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD WAS SURGICALLY ABANDONED.
Patient problems: Unspecified Infection
MAUDE report 25405630 ↗InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem
InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
LEAD WAS CAPPED DUE TO INFECTION AT THE POCKET.
Patient problems: Unspecified Infection
MAUDE report 25186214 ↗MalfunctionMay 15, 2026Adverse Event Without Identified Device or Use Problem
LEAD WAS CAPPED DUE TO OTHER/NON-PRODUCT EXPERIENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185853 ↗InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED AND SUCCESSFULLY DUE TO AN ANOMALY UNRELATED TO THE PERFORMANCE OF THE LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24974816 ↗MalfunctionMar 18, 2026Failure to Sense; Low impedance
PATIENT IMPLANTED WITH RV LEAD SUFFERED FROM TWIDDLER'S SYNDROME. THE PHYSICIAN OPTED TO PERFORM A DEVICE REVISION PROCEDURE TO SUTURE THE DEVICE DOWN IN THE POCKET TO PREVENT TWIDDLING. LEAD MEASUREMENTS WERE NOTED TO BE WITHIN NORMAL LIMITS PRIOR TO OPENING THE DEVICE POCKET. THE POCKET WAS THEN OPENED AND THE DEVICE WAS SUTURED TO THE PECTORAL MUSCLE. THE POCKET WAS THEN CLOSED AND THE LEAD WAS RETESTED. THE RV LEAD WAS NO LONGER SENSING IN BIPOLAR CONFIGURATION AND PACING IMPEDANCE MEASUREMENTS WERE LESS THAN 200 OHMS. THRESHOLD MEASUREMENTS WERE NOTED TO BE STABLE, SO SENSING WAS REPROGRAMMED TO UNIPOLAR. IT WAS NOTED THAT THE DEVICE WAS PROGRAMMED TO LEFT VENTRICULAR (LV) ONLY PACING. THIS DEVICE REMAINS IN SERVICE.
Patient problems: Twiddlers Syndrome
MAUDE report 24635112 ↗MalfunctionMar 2, 2026Positioning Problem
LEFT VENTRICULAR (LV) LEAD REVISION SCHEDULED DUE TO FAILED LV PLACEMENT AT IMPLANT 2 DAYS AGO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24489901 ↗InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem
POCKET INFECTION WAS REPORTED. PATIENT IS ON ANTIBIOTICS.
Patient problems: Unspecified Infection
MAUDE report 24318205 ↗InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem
LEAD WAS EXTRACTED DUE TO INFECTION. THIS EVENT IS RELATED TO 2183787-2026-00006.
Patient problems: Unspecified Infection
MAUDE report 24317353 ↗InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem
LEAD WAS EXTRACTED DUE TO INFECTION. THIS EVENT IS RELATED TO 2183787-2026-00007.
Patient problems: Unspecified Infection
MAUDE report 24227063 ↗MalfunctionJan 29, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem
IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) TRIGGERED A LEAD SAFETY SWITCH (LSS) DUE TO PACING IMPEDANCE MEASUREMENTS OUT OF RANGE ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) REVIEWED AND PROVIDED TROUBLESHOOTING OPTIONS. THIS PATIENT WAS SEEN IN CLINIC AND NOISE OVERSENSING WAS NOTED, AS WELL AS PACING INHIBITION GREATER THAN TWO SECONDS. TS STATED THIS IS LIKELY RELATED TO A LEAD ANOMALY. TS SUGGESTED TO HAVE THE PATIENT PERFORMED A PATIENT-INITIATED INTERROGATION (PII) UNTIL SCHEDULE FOR A REPLACEMENT. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Asystole
MAUDE report 24210066 ↗InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MalfunctionDec 11, 2025Failure to Capture; Failure to Capture
LEAD WAS PLACED A COUPLE WEEKS AGO AND NOW IT HAS NO CAPTURE. LEAD WAS CAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23782926 ↗InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LEAD WAS ABANDONED DUE TO INFECTION. THIS EVENT IS RELATED TO 2183787-2025-00058.
Patient problems: Unspecified Infection
MAUDE report 23711119 ↗InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LEAD WAS ABANDONED DUE TO INFECTION. THIS EVENT IS RELATED TO 2183787-2025-00059.
Patient problems: Unspecified Infection
MAUDE report 23710805 ↗MalfunctionDec 3, 2025Failure to Capture; Low impedance; High Capture Threshold; Failure to Capture; Low impedance; High Capture Threshold
LEAD WAS IMPLANTED AND HAD GREAT RESULTS FOR ABOUT 5 DAYS. LEAD WAS FIRMLY STILL IN THE EPICARDIUM AND HAD STARTED TO ENDOTHELISE. THE ENTIRE EPICARDIUM WAS COVERED IN SIGNIFICANT SCAR AND IT WAS SUSPECTED THAT THE LEAD WAS SCREWED INTO SCAR TISSUE. LEAD WAS SURGICALLY ABANDONED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23710056 ↗InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 23660684 ↗MalfunctionNov 24, 2025Failure to Capture; Failure to Capture
LOSS OF CAPTURE WAS NOTED. LEAD WAS CAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23639466 ↗InjuryNov 20, 2025Failure to Capture; Failure to Capture
IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE (LOC). SUBSEQUENTLY, IT WAS DECIDED TO CAP THIS LEAD AND REPLACED IT. A NEW LV LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23607542 ↗
Other Permanent Pacemaker Electrode devices
- CapSureFix Novus MRI™ SureScan® 5076-45Medtronic, Inc. · permanent pacemaker Electrode136 deaths16,004 reports
- CapSureFix Novus MRI™ SureScan® 5076-58Medtronic, Inc. · permanent pacemaker Electrode124 deaths8,405 reports
- Capsurefix® Novus 5076-45Medtronic, Inc. · permanent pacemaker Electrode85 deaths7,050 reports
- CapSureFix Novus MRI™ SureScan™ 407652Medtronic, Inc. · permanent pacemaker Electrode69 deaths6,097 reports
- SelectSecure™ MRI SureScan™ 383069Medtronic, Inc. · permanent pacemaker Electrode56 deaths4,850 reports
- Sprint Quattro Secure® 694765Medtronic, Inc. · permanent pacemaker Electrode73 deaths3,852 reports
- Attain Performa™ MRI SureScan™ 429888Medtronic, Inc. · permanent pacemaker Electrode38 deaths3,377 reports
- CapSureFix Novus MRI™ SureScan™ 407645Medtronic, Inc. · permanent pacemaker Electrode38 deaths3,370 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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