IdentityRecalls & reported problems across all models
St. Jude Medical, Inc. · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 271
- Deaths reported
- 5
- Injuries reported
- 133
- Recalls
- 0
We found 8 models of Identity by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 271 adverse event reports in the FDA's MAUDE database, received between Jun 12, 2018 and Sep 10, 2026 — classified as 5 deaths, 133 injuries, 133 malfunctions.
The most frequently reported specific device problem is “Failure to Interrogate” (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 Identity problems
Device problems
- Failure to Interrogate46
- Pacemaker Found in Back-Up Mode44
- Premature Discharge of Battery33
- Adverse Event Without Identified Device or Use Problem27
- Data Problem25
- Failure to Disconnect25
- Misconnection13
- Incorrect Measurement12
Patient problems
- No Known Impact Or Consequence To Patient128
- No Clinical Signs, Symptoms or Conditions94
- Unspecified Infection17
- No Consequences Or Impact To Patient14
- Death6
- Pocket Erosion6
- Arrhythmia4
- Discomfort4
Identity models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Identity™ 5386implantable pacemaker Pulse-generator3 deaths154 reports
- Identity™ 5286implantable pacemaker Pulse-generator53 reports
- Identity™ 5376implantable pacemaker Pulse-generator1 death26 reports
- Identity® 5480implantable pacemaker Pulse-generator21 reports
- Identity® 5180Programmer, pacemaker9 reports
- Identity® ADx DRimplantable pacemaker Pulse-generator1 death6 reports
- Identity® SRProgrammer, pacemaker1 report
- Identity® DRimplantable pacemaker Pulse-generator1 report
Recent Identity adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Loose or Intermittent Connection; Failure to Disconnect
It was reported that the patient presented to hospital for a generator change procedure. During the procedure, it was reported that the set screw of the right atrial (RA) lead was stripped resulting in the RA lead unable to remove from the header of the pacemaker. The RA lead was capped and the pacemaker was explanted. The patient was discharged post procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50708042 ↗InjurySep 3, 2025Computer Operating System Problem; Unexpected Mode Switch; Computer Operating System Problem; Unexpected Mode Switch
IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR A ROUTINE CHECK-UP. UPON INTERROGATION IT WAS NOTED THAT THE PACEMAKER EXHIBITED BACKUP MODE AND FIRMWARE CORRUPTION DUE TO DEVICE END OF LIFE. AS A RESOLUTION THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22959796 ↗MalfunctionAug 22, 2025Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR FOLLOW UP, THE PACEMAKER WAS UNABLE TO BE INTERROGATED. NO INTERVENTION OR PROCEDURE WAS REPORTED. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22870554 ↗MalfunctionJul 23, 2025Failure to Disconnect; Contamination of Device Ingredient or Reagent; Failure to Disconnect; Contamination of Device Ingredient or Reagent
DURING AN ELECTIVE REPLACEMENT PROCEDURE, IT WAS NOT POSSIBLE TO REMOVE THE LEAD FROM THE HEADER OF THE DEVICE. THE SUSPECTED CAUSE OF THE EVENT WAS DUE TO A FOREIGN SUBSTANCE IN THE HEADER. THE DEVICE WAS EXPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22575957 ↗MalfunctionFeb 20, 2025Data Problem; Data Problem
DURING AN IN CLINIC FOLLOW UP, THE DEVICE WAS INTERROGATED, AND INVALID CHARACTERS RESULTED IN A DEVICE ERROR. TECHNICAL SUPPORT WAS CONTACTED AND A PROGRAMMER INTERROGATION WOULD CLEAR THE DATA CORRUPTION. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21426549 ↗MalfunctionDec 5, 2024Failure to Disconnect; Failure to Disconnect
DURING A ROUTINE DEVICE EXCHANGE, THE SET SCREW OF THE RIGHT ATRIAL (RA) PORT IN THE HEADER OF THE DEVICE WAS UNABLE TO LOOSEN. THE RA LEAD WAS CUT, AND THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED TO RESOLVE THIS EVENT. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20858952 ↗MalfunctionOct 4, 2024Incorrect Measurement; Incorrect Measurement
DURING AN IN CLINIC FOLLOW UP, DIAGNOSTIC DATA WAS NOT SHOWN FROM THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND REINTERROGATION OF THE DEVICE WAS RECOMMENDED TO CLEAR THE DIAGNOSTIC DATA. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20370064 ↗InjuryJun 11, 2024Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem
IT WAS REPORTED THAT A PATIENT PRESENTED WITH OVER-SENSING RESULTING IN INAPPROPRIATE AUTOMATIC MODE SWITCH. THIS WAS ALLEGED TO BE DUE TO INSULATION BREACH ON THE RIGHT ATRIAL COMPETITOR LEAD. NO INTERVENTION WAS REPORTED, AND THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19512735 ↗InjuryJun 4, 2024Unexpected Mode Switch; Unexpected Mode Switch
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW OF THE TRANSMISSION, IT WAS NOTED THAT THE PACEMAKER WAS FOUND IN BACKUP MODE. NO INTERVENTION WAS PERFORMED. THE PATIENT CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19456661 ↗MalfunctionMar 13, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR GENERATOR CHANGE. DURING PROCEDURE IT WAS NOTED THAT THE HEX WRENCH WOULD NOT ENGAGE THE SET SCREW ON THE PACEMAKER. A BACKOUT SURGICAL TOOL WAS BROUGHT IN TO REMOVE THE SETSCREWS AND THE PACEMAKER WAS REPLACED SUCCESSFULLY. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18898360 ↗MalfunctionJan 15, 2024Loose or Intermittent Connection; Difficult to Remove; Failure to Disconnect; Loose or Intermittent Connection; Difficult to Remove; Failure to Disconnect
RELATED MFR REPORT NUMBER: 2017865-2024-01126. IT WAS REPORTED THAT DURING A PROCEDURE THAT THE RIGHT VENTRICULAR (RV) LEAD WAS UNABLE TO BE REMOVED FROM THE PACEMAKER (PM) HEADER AND WAS DAMAGED. THE SET SCREW OF THE HEADER WAS STRIPPED AND WAS UNABLE TO BE REMOVED. THE PHYSICIAN ELECTED TO CAP AND REPLACE THE RV LEAD AND EXPLANT AND REPLACE THE PM. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18510899 ↗InjuryJan 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INSPECTION, IT WAS NOTED THAT THE PATIENT HAD POCKET INFECTION AND EROSION. THE POCKET WAS RED, SWOLLEN AND HAD DISCHARGE. THE PACEMAKER SYSTEM WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 18461478 ↗InjuryDec 5, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
RELATED MANUFACTURING REFERENCE NUMBER: 2017865-2023-93942 RELATED MANUFACTURING REFERENCE NUMBER: 2017865-2023-93943 IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH CAPTURE THRESHOLD MEASUREMENTS. THE RA LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD AND THE PULSE GENERATOR WERE EXPLANTED AND REPLACED FOR UNKNOWN REASON. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18271843 ↗MalfunctionOct 23, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent
RELATED MANUFACTURER REPORT NUMBER: 2017865-2023-50404, 2017865-2023-50405, 2017865-2023-50406. DURING A DEVICE REPLACEMENT PROCEDURE FOR NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI), THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE CAPPED AND REPLACED. THE RA LEAD WAS REPLACED DUE TO NOISE OBSERVED AND THE RV LEAD WAS REPLACED DUE TO PROBE PROTRUSION. ADDITIONALLY, IT WAS OBSERVED THAT BLOOD HAD LEAKED INTO THE DEVICE HEADER OF THE OLD DEVICE AND THAT BLOOD WAS OBSERVED IN THE NEW DEVICE HEADER. THE NEW DEVICE WAS EXPLANTED AND REPLACED DURING THE PROCEDURE TO RESOLVE THE EVENT. THE PATIENT WAS STABLE FOLLOWING THE REPLACEMENT OF THE LEADS AND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17987866 ↗MalfunctionOct 13, 2023Failure to Disconnect; Failure to Disconnect
RELATED MANUFACTURER REPORT NUMBER: 2017865-2023-48457 IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A SCHEDULED GENERATOR CHANGE OUT PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE RIGHT ATRIAL (RA) LEAD HAD FAILED TO BE DISCONNECTED FROM THE HEADER OF THE PACEMAKER. THE PACEMAKER WAS EXPLANTED AND REPLACED, WHILE THE RA LEAD WAS CAPPED DURING THE SAME PROCEDURE ON (B)(6) 2023. THE PATIENT HAD NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17935109 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
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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