Microny™ 2525TRecalls & reported problems
St. Jude Medical, Inc. · Pulse GeneratorSSIR · Class 3 · Implant
Quick summary
This St. Jude Medical Microny pacemaker has 86 adverse event reports: 38 injuries, 47 malfunctions and 1 death. The reports mostly describe batteries running down early, the device failing to respond to checks or pace the heart, and pocket pain or erosion, sometimes requiring replacement. 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
- 88
- Deaths reported
- 1
- Injuries reported
- 40
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 05414734006224), received between Jun 18, 2018 and Sep 30, 2026 — classified as 1 death, 40 injuries, 47 malfunctions.
The most frequently reported specific device problem is “Premature Discharge of Battery” (23 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Premature Discharge of Battery23
- Failure to Interrogate17
- No Pacing13
- Adverse Event Without Identified Device or Use Problem8
- Failure to Capture8
- Incorrect Measurement7
- Battery Problem6
- Data Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- No Known Impact Or Consequence To Patient31
- Arrhythmia6
- Discomfort5
- Dizziness3
- Syncope3
- Syncope/Fainting3
- Unspecified Infection3
Recent adverse event reports
The 25 most recent of 88 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Premature Discharge of Battery; Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952741 ↗InjurySep 25, 2026Premature Discharge of Battery; Battery Problem
During an in-clinic follow-up, an increase in battery impedance was observed on the device. Premature battery depletion was suspected but not confirmed. A revision procedure was performed. The device was explanted to resolve the event. The patient is stable with no consequences. Further information has been requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903232 ↗InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET PAIN DUE TO THEIR PACEMAKER. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: Discomfort
MAUDE report 24767170 ↗MalfunctionMar 30, 2026Incorrect Measurement
IT WAS REPORTED THAT A PATIENT PRESENTED WITH AN INCORRECT DIAGNOSTIC ISSUE NOTED ON THE PATIENT'S PACEMAKER. RE-EXAMINATION NOTED NOMINAL VALUES ON THE DEVICE. NO ADDITIONAL INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24708801 ↗MalfunctionFeb 4, 2026Loose or Intermittent Connection
DURING IMPLANT PROCEDURE, THE SET SCREW OF THE HEADER OF THE DEVICE WAS NOT ABLE TO BE TIGHTENED. THE DEVICE WAS NOT IMPLANTED, AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED TO RESOLVE THIS EVENT. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258032 ↗MalfunctionDec 2, 2025No Pacing; No Pacing
DURING AN INITIAL IMPLANT PROCEDURE, THE DEVICE WAS NOT PACING THE PATIENT. THE DEVICE WAS EXPLANTED, AND A NEW DEVICE WAS USED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23693743 ↗MalfunctionNov 18, 2025Break; Loose or Intermittent Connection; Failure to Disconnect; No Pacing; Break; Loose or Intermittent Connection; Failure to Disconnect; No Pacing
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR SCHEDULED IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PACEMAKER EXHIBITED NO LOW-VOLTAGE OUTPUT, PROMPTING DISCONNECTION AND RECONNECTION OF THE LEAD. THE PATIENT EXPERIENCED ASYSTOLE DURING THIS PROCESS. WHILE ATTEMPTING TO DISCONNECT THE LEAD, IT COULD NOT BE REMOVED FROM THE HEADER, LIKELY DUE TO STRIPPING OF THE SET SCREW. THE PACEMAKER HEADER WAS DAMAGED. THE DEVICE WAS REPLACED WITH AN ALTERNATE PACEMAKER ON (B)(6) 2025.THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: Arrhythmia
MAUDE report 23586785 ↗InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS PRESENTED AT THE HOSPITAL DUE TO POCKET EROSION. SWAB TESTS WERE PERFORMED AND THE CULTURE RESULTS CAME BACK NEGATIVE WITH NO GROWTH PRESENT. THE POCKET WAS CLEANED AND PACEMAKER REPOSITIONED ON (B)(4) 2025. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Pocket Erosion
MAUDE report 23447895 ↗InjuryJun 24, 2025Premature Discharge of Battery; Failure to Interrogate; No Pacing; Premature Discharge of Battery; Failure to Interrogate; No Pacing
IT WAS REPORTED THAT THE PATIENT HAD SYNCOPE. DURING FOLLOW-UP, THE DEVICE COULD NOT BE INTERROGATED AND DID NOT RESPOND TO A MAGNET. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: Syncope/Fainting
MAUDE report 22319671 ↗MalfunctionApr 18, 2025Failure to Interrogate; Migration or Expulsion of Device; Failure to Interrogate; Migration or Expulsion of Device
ADDITIONAL INFORMATION WAS RECEIVED INDICATING DIAGNOSTIC IMAGING WAS PERFORMED AND MIGRATION OF THE DEVICE WAS OBSERVED. THE DEVICE WAS SUCCESSFULLY ABLE TO BE INTERROGATED. THE PHYSICIAN SUSPECTED THE INABILITY TO INTERROGATE WAS DUE TO THE DEVICE BEING IN A DIFFERENT POSITION THAN ANTICIPATED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21867886 ↗InjuryMar 27, 2025Premature Discharge of Battery; Premature Discharge of Battery
DURING FOLLOW-UP, THE PATIENT EXPERIENCED FATIGUE. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: Fatigue
MAUDE report 21713442 ↗MalfunctionOct 24, 2024Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER WAS UNABLE TO BE INTERROGATED. NO INTERVENTION WAS PERFORMED. THE CONDITION OF THE PATIENT IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20520185 ↗MalfunctionSep 20, 2024Data Problem; Data Problem
IT WAS REPORTED THAT THE PACEMAKER EXHIBITED ERROR MESSAGE. NO PROGRAMMING CHANGES WERE MADE AND THE PACEMAKER CONTINUED WITH THE INTERROGATION. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20274687 ↗InjuryAug 6, 2024No Pacing; No Pacing
IT WAS REPORTED THAT THE PATENT PRESENTED IN CLINIC WITH A PACEMAKER THAT TRIGGERED THE ELECTIVE REPLACEMENT INDICATOR. IT WAS NOTED THAT THE PACEMAKER WAS NOT PACING. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS RECOVERING.
Patient problems: Discomfort; Dizziness
MAUDE report 19919104 ↗InjuryMay 16, 2024Premature Discharge of Battery; Pacing Problem; Battery Problem; Premature Discharge of Battery; Pacing Problem; Battery Problem
IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A PACEMAKER EXHIBITING AN OUTPUT RATE ISSUE. INTERROGATION REVEALED THE PACEMAKER EXHIBITED A BATTERY IMPEDANCE PROBLEM AND THAT THE BATTERY WAS PREMATURELY DEPLETED. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE BEFORE, DURING AND AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19332694 ↗MalfunctionMar 19, 2024Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED FAILURE TO INTERROGATE DUE TO LOSS OF RADIO FREQUENCY ON THE PACEMAKER. NO CHANGES OR INTERVENTIONS WERE PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18938094 ↗InjuryMar 7, 2024Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED A PATIENT'S PACEMAKER PRESENTED WITH A DIAGNOSTIC ISSUE IN WHICH IT STRUGGLED TO MAKE PROGRAMMING CHANGES. THE DEVICE WAS EXPLANTED AND REPLACED IN A PROCEDURE ON (B)(6) 2024. POST-PROCEDURE THE PATIENT WAS DISCHARGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18862297 ↗InjuryFeb 14, 2024Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate
IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. THE PHYSICIAN SUSPECTED PREMATURE BATTERY DEPLETION OF THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18708003 ↗InjuryDec 24, 2023Failure to Capture; Incorrect Measurement; Failure to Capture; Incorrect Measurement
IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC. UPON EXAMINATION PATIENT'S PACEMAKER WAS FOUND TO HAVE LOST CAPTURE AND EXHIBITED DIAGNOSTIC ANOMALY OF INABILITY TO DISPLAY BATTERY LONGEVITY. THIS RESULTED IN A SUSTAINED PATIENT BRADYCARDIA. THE DEVICE WAS EXPLANTED ON (B)(6) 2023. NO FURTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Arrhythmia
MAUDE report 18389870 ↗InjuryNov 2, 2023Failure to Capture; Therapy Delivered to Incorrect Body Area; Failure to Capture; Therapy Delivered to Incorrect Body Area
DURING AN ELECTIVE DEVICE EXCHANGE PROCEDURE, EXTRACARDIAC MUSCLE STIMULATION WAS OBSERVED. BECAUSE OF THIS, THE DEVICE WAS REPOSITIONED IN THE POCKET, WHICH RESOLVED THE MUSCLE STIMULATION. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION. THE FOLLOWING DAY, A LOSS OF CAPTURE WAS OBSERVED ON THE DEVICE. UPON INVESTIGATION, THE CAPTURE THRESHOLD RETURNED TO NORMAL WHEN THE DEVICE WAS POCKET WAS MANUALLY PRESSED. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE DEVICE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Discomfort
MAUDE report 18057231 ↗InjurySep 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED, THAT THE PATIENT PRESENTED IN CLINIC WITH POCKET EROSION AND INFECTION. THE PACEMAKER SYSTEM WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 17717038 ↗MalfunctionSep 8, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, THE PULSE GENERATOR'S SET SCREW WAS UNABLE TO BE SCREWED ON. THE PULSE GENERATOR WAS NOT USED AND A NEW ONE WAS IMPLANTED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17715835 ↗InjuryJun 13, 2023Premature Discharge of Battery; No Pacing; Premature Discharge of Battery; No Pacing
IT WAS REPORTED VIA PRODUCT RECEIPT THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND THAT THE PACEMAKER (PM) EXHIBITED NO PACING DUE TO POSSIBLE PREMATURE BATTERY DEPLETION. PATIENT HAD EXPERIENCED BRADYCARDIA. THE PM WAS EXPLANTED AND REPLACED. PATIENT CONDITION WAS NOT PROVIDED.
Patient problems: Arrhythmia; No Clinical Signs, Symptoms or Conditions
MAUDE report 17115213 ↗MalfunctionMay 12, 2023Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE PACEMAKER EXHIBITED A DIAGNOSTIC ISSUE. THE DEVICE WILL CONTINUE TO BE MONITORED. THE PATIENT WAS STABLE AND ASYMPTOMATIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16924222 ↗MalfunctionApr 13, 2023Failure to Interrogate; Interrogation Problem; Failure to Interrogate; Interrogation Problem
IT WAS REPORTED THAT THE DEVICE WAS SUCCESSFULLY INTERROGATED AT A LATER DATE TO RESOLVE THE EVENT AND THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16733850 ↗
Other Pulse-generator, single chamber, sensor driven, implantable devices
- Gallant™ CDHFA500BSt. Jude Medical, Inc. · Pulse-generator, single chamber, sensor driven, implantable29 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.