Durata™ 7121-60Recalls & reported problems
St. Jude Medical, Inc. · Defibrillation Lead · Class 3 · Implant
Quick summary
This Durata 7121-60 defibrillation lead is implanted under the skin to deliver shock therapy from a St. Jude Medical implantable cardioverter defibrillator. The 71 reports mostly describe the lead picking up noise or oversensing so the device may inhibit or misfire, high or low defibrillation impedance, intermittent failure to pace or capture, and lead dislodgement or fracture seen on imaging. Reports mention 4 deaths and 35 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
- 72
- Deaths reported
- 4
- Injuries reported
- 35
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 05414734502115), received between Jun 20, 2018 and Sep 7, 2026 — classified as 4 deaths, 35 injuries, 33 malfunctions.
The most frequently reported specific device problem is “High impedance” (27 reports).
3 other recalls cover devices cleared under the same FDA submission (P950022); they may or may not involve this specific model.
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
- High impedance27
- Over-Sensing21
- Signal Artifact/Noise16
- Adverse Event Without Identified Device or Use Problem8
- Failure to Capture8
- Fracture5
- High Capture Threshold4
- Inappropriate/Inadequate Shock/Stimulation4
Patient problems
- No Known Impact Or Consequence To Patient30
- No Clinical Signs, Symptoms or Conditions26
- No Information5
- Death4
- Shock from Patient Lead(s)3
- Therapeutic Effects, Unexpected3
- Insufficient Information2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 7, 2026Signal Artifact/Noise; High impedance
New information received indicates that the patient presented in the clinic for follow up. It was noted that the right ventricular (RV) lead exhibited noise issue. The RV lead was explanted and replaced. The patient was in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50658436 ↗MalfunctionMay 27, 2026High impedance
NEW INFORMATION RECEIVED INDICATES THAT NO INTERVENTION WAS PERFORMED, AND THE PATIENT WOULD CONTINUE TO BE MONITORED. THE PATIENT'S CONDITION REMAINED STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25310654 ↗MalfunctionMay 7, 2026Failure to Capture
IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD DISPLAYED INTERMITTENT CAPTURE. PROGRAMMING CHANGES WERE MADE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25112190 ↗InjuryMar 24, 2026Failure to Capture; Over-Sensing; Device Dislodged or Dislocated
NEW INFORMATION RECEIVED INDICATES THAT FLUOROSCOPY IMAGING WAS PERFORMED AND REVEALED RV LEAD DISLODGEMENT.
Patient problems: Dizziness; Syncope/Fainting
MAUDE report 24678011 ↗InjuryDec 27, 2023Over-Sensing; Over-Sensing
IT WAS REPORTED THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, IT WAS DISCOVERED THE RIGHT VENTRICULAR LEAD WAS OVERSENSING NOISE. NO CHANGES OR INTERVENTIONS WERE REPORTED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18404942 ↗InjuryDec 17, 2023Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION NOTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE OVERSENSING. THE REPORTED LEAD WAS CAPPED AND REPLACED ON (B)(6) 2023. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18342272 ↗MalfunctionSep 28, 2023Low impedance; Low impedance
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED LOW DEFIBRILLATION IMPEDANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17840245 ↗MalfunctionSep 12, 2023High impedance; High impedance
RELATED MANUFACTURE REFERENCE NUMBER: 2017865-2023-42822. IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY. REVIEW OF TRANSMISSION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED FAILURE TO CAPTURE AND THE DEVICE REGISTERED HIGH DEFIBRILLATION IMPEDANCES. NO INTERVENTIONS WERE PERFORMED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17729188 ↗MalfunctionJun 13, 2023Over-Sensing; Over-Sensing
RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT DURING A FOLLOW-UP EVALUATION, A SINGLE EPISODE OF OVERSENSING NOISE CAUSING PACING INHIBITION WAS NOTED. THE PATIENT WAS ASYMPTOMATIC. THE PATIENT COULD NOT RECALL IF SHE HAD A MEDICAL PROCEDURE AROUND THAT TIME. THE NOISE WAS NOT REPRODUCED. NO INTERVENTION WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17122184 ↗MalfunctionJun 7, 2023High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR REMOTE FOLLOW -UP VIA MERLIN.NET. A DEVICE INTERROGATION REVEALED HIGH DEFIBRILLATION IMPEDANCE EXHIBITED BY THE RIGHT VENTRICULAR LEAD. SUBSEQUENT PROGRAMMING INTERVENTIONS WERE ATTEMPTED. HOWEVER, THE RIGHT VENTRICULAR COIL IMPEDANCE WAS STILL ELEVATED. NO FURTHER INTERVENTIONS WERE REPORTED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17083222 ↗InjuryJan 27, 2023High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-04373. IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH IMPEDANCE. THE PATIENT WAS SCHEDULED FOR A LEAD REPLACEMENT. DURING THE EXPLANT PROCEDURE OF THE RIGHT VENTRICULAR LEAD, THE RIGHT ATRIAL LEAD DISLODGED. BOTH LEADS WERE EXPLANTED AND REPLACED. THE PATIENT WAS STABLE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16258736 ↗InjuryJan 25, 2023Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance
IT WAS REPORTED THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THE RIGHT VENTRICULAR LEAD EXHIBITED A FAILURE TO CAPTURE AND HAD A STEADY RISE IN PACING IMPEDANCE OVER THE PAST YEAR. IT WAS SUGGESTED THE CAUSE WAS EITHER A LEAD FRACTURE OR CALCIFICATION AT THE LEAD TIP. THE RIGHT VENTRICULAR LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS DISCHARGED FOLLOWING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16244543 ↗InjuryJan 17, 2023High impedance; High impedance
IT WAS REPORTED THAT PRIOR TO A DEVICE CHANGE OUT PROCEDURE ON (B)(6) 2023, HIGH PACING LEAD IMPEDANCE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS CAPPED, AND A NEW RV LEAD WAS IMPLANTED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES, THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16184383 ↗MalfunctionDec 13, 2022Fracture; High impedance; Fracture; High impedance
IT WAS REPORTED THAT HIGH RV LEAD IMPEDANCE WAS OBSERVED. POSSIBLE LEAD FRACTURE WAS NOTED. REPLACING THE LEAD WAS SUGGESTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15974318 ↗MalfunctionNov 7, 2022Over-Sensing; Over-Sensing
RELATED MANUFACTURER REPORT NUMBER: 2017865-2022-44497. DURING REMOTE MONITORING, EPISODES OF OVERSENSING WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS. NO INTERVENTION WAS PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15744334 ↗InjuryAug 19, 2022Break; High impedance; Capturing Problem; Break; High impedance; Capturing Problem
IT WAS REPORTED THAT THE PACING LEAD IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD HAD SLOWLY INCREASED SINCE (B)(6) 2021 AND WAS NOW ABOVE THE NORMAL RANGE. AN INSULATION BREACH WAS SUSPECTED THOUGH NO SIGN OF LEAD DAMAGE WAS NOTICEABLE ON CHEST X-RAY. THE RV LEAD WAS CAPPED (B)(6) 2022 AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15260245 ↗InjuryJul 27, 2022Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVER-SENSING. LEAD REVISION WAS DISCUSSED, BUT NO INTERVENTIONS WERE MADE OR REPORTED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15115407 ↗MalfunctionJun 1, 2022High impedance; Impedance Problem; High impedance; Impedance Problem
IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED HIGH PACING IMPEDANCE AND VARYING LOW VOLTAGE IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. NO CHANGES OR INTERVENTION WERE PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14570476 ↗MalfunctionFeb 28, 2022High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR LEAD EXHIBITED HIGH DEFIBRILLATION IMPEDANCE. FURTHER INFORMATION WAS NOT REPORTED. THE PATIENT'S CONDITION WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 13625904 ↗MalfunctionJan 5, 2022Over-Sensing; Over-Sensing
RELATED MANUFACTURE REFERENCE NUMBER: 2017865-2022-00040. IT WAS REPORTED THAT THE PATIENT PRESENTED DURING CLINICAL FOLLOW-UP. UPON INTERROGATION, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD) AND RIGHT VENTRICULAR LEAD(RV LEAD) EXHIBITED POST PACED T WAVE OVERSENSING. PROGRAMMING CHANGE WERE PERFORMED FOR BOTH ICD AND RV LEAD. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13169917 ↗MalfunctionJan 4, 2022Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 13158861 ↗MalfunctionNov 23, 2021High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. UPON REVIEW, IT WAS DISCOVERED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH IMPEDANCE. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12865664 ↗InjuryJul 7, 2021High impedance; Over-Sensing; High impedance; Over-Sensing
IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC. UPON INTERROGATION, THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED POST-SENSED T-WAVE OVERSENSING AND HIGH PACING IMPEDANCE. HIGH VOLTAGE THERAPIES WERE TURNED OFF AND THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2021. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12129851 ↗MalfunctionJul 6, 2021Over-Sensing; Over-Sensing
IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY VIA MERLIN.NET. THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD WAS OVERSENSING NOISE. THE PATIENT WAS ASYMPTOMATIC. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12124738 ↗InjuryJul 6, 2021High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-24928. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD WAS FAILING TO CAPTURE AND HAD LOW PACING IMPEDANCE. FURTHER, THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED TO HAVE HIGH PACING IMPEDANCE. THE PATIENT WAS ASYMPTOMATIC. THE RA AND RV LEADS WERE CAPPED AND REPLACED ON (B)(6) 2021. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12122258 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P950022. One submission often covers many models, so check the product and lot details in each record.
- Z-0660-2016 · Nov 3, 2015 · TerminatedOptisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Car
- Z-0458-2012 · Nov 28, 2011 · TerminatedSt. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata(7Fr), Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042 Product Usage: These Silicone transvenous
- Z-0457-2012 · Nov 28, 2011 · TerminatedSt. Jude Medical Riata (8Fr), Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592 Product Usage: These Silicone transvenous high voltage (HV) leads co
Other Implantable cardioverter defibrillator (non-CRT) devices
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- Cobalt™ XT DR MRI SureScan™ DDPA2D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)3 recalls30 deaths1,603 reports
- ENDOTAK RELIANCE® G 0185Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,632 reports
- VIGILANT™ EL ICD DR D233Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,563 reports
- Evera MRI™ XT DR SureScan® DDMB1D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)1 recall35 deaths1,426 reports
- Durata™ 7122St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)27 deaths1,377 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.