Tendril™ SDX (REF 1688TC-40)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05414734504812), received between Jun 21, 2018 and Aug 30, 2021 — classified as 2 deaths, 10 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Low impedance” (6 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.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2021High impedance; Over-Sensing; Pacing Problem; High impedance; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD HAD HIGH PACING IMPEDANCE AND WAS OVERSENSING NOISE LEADING TO INAPPROPRIATE AUTOMATIC MODE SWITCH (AMS). THE PATIENT WAS ASYMPTOMATIC. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388365 ↗
• InjuryFeb 16, 2021Failure to Capture

  IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED NO CAPTURE IN BIPOLAR OR UNIPOLAR CONFIGURATIONS. THE ATRIAL LEAD WAS CAPPED 9 FEB, 2021 AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11335938 ↗
• InjuryJan 28, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD EXHIBITED NOISE OVER-SENSING. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2021. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11248029 ↗
• MalfunctionDec 29, 2020Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC WITH AN ARRHYTHMIA. UPON INTERROGATION, THE RIGHT ATRIAL LEAD EXHIBITED OVERSENSING NOISE WHICH CAUSED INAPPROPRIATE AUTOMATIC MODE SWITCHES. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Arrhythmia

  MAUDE report 11092477 ↗
• MalfunctionNov 12, 2020Low impedance; Low impedance

  IT WAS REPORTED THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC. UPON INTERROGATION, IT WAS OBSERVED THE ATRIAL LEAD HAD LOW PACING IMPEDANCE BELOW 100 OHMS. NO INTERVENTION OR PROGRAMMING CHANGES WERE COMPLETED. THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10830153 ↗
• InjuryJul 21, 2020Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY. REVIEW OF THE TRANSMISSIONS REVEALED THAT THE RIGHT ATRIAL LEAD WAS OVERSENSING NOISE, AND WAS CONFIRMED IN CLINIC. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2020, AND THE PATIENT WAS IN STABLE CONDITION THROUGHOUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10305316 ↗
• MalfunctionFeb 28, 2020High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR ROUTINE GENERATOR CHANGE WITH THE RIGHT ATRIAL LEAD EXHIBITING HIGH CAPTURE THRESHOLDS. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2020. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9772400 ↗
• InjuryJan 9, 2020Break; Over-Sensing; Break; Over-Sensing

  RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2020-00131. IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR LEAD THAT CAUSED INHIBITION OF PACING AND OVERSENSING ON THE RIGHT ATRIAL LEAD. CLAVICULAR CRUSH WAS SUSPECTED ON BOTH THE RV AND RA LEADS. THE LEADS WERE CAPPED AND REPLACED ON (B)(6) 2019. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9570214 ↗
• InjuryAug 22, 2019Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT ATRIAL LEAD NOISE WAS NOTED ON THE STORED ELECTROCARDIOGRAM. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2019. PATIENT'S CONDITION WAS STABLE BEFORE AND AFTER THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8923152 ↗
• InjuryAug 9, 2019Low impedance; Electrical Shorting; Low impedance; Electrical Shorting

  IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED AN ELECTRICAL SHORT WITH LOW LEAD IMPEDANCE ANOMALY. ON (B)(6) 2019, THE LEAD WAS CAPPED AND REPLACED SUCCESSFULLY. THE PATIENT CONDITION WAS STABLE THROUGHOUT THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8881231 ↗
• InjuryAug 2, 2019Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED VIA REMOTE TRANSMISSION. THE PATIENT'S ATRIAL LEAD EXHIBITED HIGH IMPEDANCE. LEAD FRACTURE WAS SUSPECTED. ON (B)(6) 2019, THE PATIENT WAS BROUGHT INTO CLINIC AND TESTING REVEALED HIGH IMPEDANCE. LEAD REPLACEMENT WAS DISCUSSED, BUT NOT PERFORMED. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8855595 ↗
• MalfunctionJul 1, 2019Signal Artifact/Noise; Low impedance; Signal Artifact/Noise; Low impedance

  IT WAS REPORTED THAT WHEN A SYMPTOMATIC PATIENT PRESENTED IN EMERGENCY ROOM AFTER FEELING A VIBRATORY ALERT, LOW IMPEDANCE AND NOISE WERE NOTED ON THE RA LEAD. NOISE REVERSION ALERT WAS ALSO NOTED. PROGRAMMING CHANGES WERE MADE FOR IMPEDANCE ISSUE. PATIENT WAS ASYMPTOMATIC TO NOISE EPISODES AND CONTINUES TO BE MONITORED.

  Patient problems: Discomfort

  MAUDE report 8750975 ↗
• InjuryDec 6, 2018Signal Artifact/Noise; Low impedance; Signal Artifact/Noise; Low impedance

  IT WAS REPORTED THAT RIGHT ATRIAL (RA) LEAD NOISE CAUSED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR TO USE DISCRIMINATION CHANNEL INCORRECTLY AND LED TO DELIVER INAPPROPRIATE SHOCKS. THE RA LEAD ALSO TRIGGERED PATIENT NOTIFIER FOR LOW ATRIAL IMPEDANCE ON (B)(6) 2018. THE DEVICE WAS REPROGRAMMED AND ULTIMATELY EXPLANTED AND REPLACED ALONG WITH THE RA LEAD ON (B)(6) 2018. THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 8138756 ↗
• DeathNov 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS BRAIN DEATH, CARDIAC ARREST, AND VALVULAR HEART DISEASE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Death

  MAUDE report 8108066 ↗
• MalfunctionNov 6, 2018Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD WAS CAPPED ON (B)(6) 2018 DURING AN UNRELATED PROCEDURE DUE TO A LOW VOLTAGE IMPEDANCE ANOMALY. THE LEAD WAS REPLACED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8044499 ↗
• InjuryAug 29, 2018Failure to Capture; Device Sensing Problem; Failure to Capture; Device Sensing Problem

  IT WAS REPORTED THAT A DAY AFTER NORMAL GENERATOR CHANGE OUT, THE RIGHT ATRIAL (RA) LEAD P WAVES WERE LOW AND WAS NOT CAPTURING AT FULL OUTPUT. WHOLE SYSTEM WAS MOVED TO THE RIGHT SIDE DUE TO PATIENT¿S ISSUE. NEW LEADS WERE USED. THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7828058 ↗
• InjuryJul 23, 2018Signal Artifact/Noise; Low impedance; Signal Artifact/Noise; Low impedance

  IT WAS REPORTED THAT THE PATIENT¿S RIGHT ATRIAL LEAD WAS CAPPED AND REPLACED ON (B)(6) 2018 DUE TO LEAD NOISE AND LOW, OUT-OF-RANGE IMPEDANCE. THE PATIENT¿S RIGHT VENTRICULAR LEAD¿S CAPTURE THRESHOLD WAS IN RANGE AND STABLE WHEN TESTED DURING THE PROCEDURE. HOWEVER, THE LEAD WAS ALSO CAPPED AND REPLACED ON (B)(6) 2018 DUE TO PREVIOUSLY NOTED HIGH CAPTURE THRESHOLDS. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7710388 ↗
• DeathJun 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS DECEASED.  THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED.  THE CAUSE OF DEATH WAS A VENTRICULAR TACHYCARDIA STORM.  NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Death

  MAUDE report 7627745 ↗