NA 5866-38MRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00681490136907), received between Apr 18, 2017 and May 28, 2024 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Signal Artifact/Noise” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST IMPLANTABLE PULSE GENERATOR (IPG) CHANGE OUT, THE PATIENT DEVELOPED AN INFECTION. THE IPG SYSTEM WAS EXPLANTED. A TEMPORARY WIRE WAS PLACED BEFORE A LEADLESS IPG WAS IMPLANTED A DAY LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19403656 ↗
• InjuryOct 12, 2022Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT NON-CAPTURE WERE OBSERVED ON THE TWO RIGHT ATRIAL (RA) EPICARDIAL LEADS WHILE USING AN ADAPTOR. THE PACING LEADS AND ADAPTOR WERE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15586026 ↗
• InjuryJul 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST-IMPLANT THE PATIENT EXPERIENCED AN INFECTION WITH POCKET DRAINAGE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM, WITH THE EXCEPTION OF THE RIGHT ATRIAL (RA) LEAD, WAS EXPLANTED. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE IPG WAS REPLACED AND THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 14904473 ↗
• MalfunctionAug 18, 2021Break; Break

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) TRANSVENOUS DEFIBRILLATOR COIL HAD A CONFIRMED FRACTURE. THE LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED. IT WAS FURTHER REPORTED THAT THE PIN PLUG ADAPTOR HAD AN INSULATION DAMAGE WHERE EXPOSED METAL WAS VISIBLE. THE ADAPTOR WAS TESTED AND FOUND TO BE WORKING AS NORMAL. THE PIN PLUG ADAPTOR REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338080 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF HAVING A SKIN BOIL ABOVE WHERE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IMPLANTED. THE PATIENT WAS INITIALLY TREATED WITH INTRAVENOUS ANTIBIOTICS. THE ICD SYSTEM WAS THEN REMOVED DUE TO INFECTION. THE PATIENT WAS PROVIDED WITH LIFEVEST BEFORE BEING DISCHARGED HOME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Skin Inflammation; Unspecified Infection

  MAUDE report 10782040 ↗
• InjuryOct 2, 2020Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AS IT WAS NEARING ELECTIVE REPLACEMENT INDICATOR (ERI).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10618647 ↗
• InjuryAug 14, 2019Signal Artifact/Noise; High impedance; Impedance Problem; Signal Artifact/Noise; High impedance; Impedance Problem

  IT WAS REPORTED THAT BOTH THE LEFT VENTRICULAR (LV) LEAD AND ADAPTER HAD HIGH IMPEDANCE MEASUREMENTS. IT WAS NOTED THAT THE LV TIP ELECTRODE IMPEDANCE HAD A HIGH DEGREE OF VARIABILITY WITH ISOMETRIC LEFT ARM MOVEMENTS. IT WAS ALSO NOTED THAT NOISE WAS PRESENT ON THE ELECTROGRAM (EGM). IT WAS NOTED THAT REPROGRAMMING WAS DONE, AND BOTH LEADS WERE TURNED OFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8894039 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WAS REMOVED. THE LEFT VENTRICULAR (LV) LEADS WERE CAPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8452478 ↗
• InjuryMar 5, 2019Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THERE WAS OVERSENSING DUE TO NOISE. IT COULD NOT BE IDENTIFIED WHETHER THE NOISE IS COMING FROM ONE OF THE LEADS OR THE ADAPTER. THE LEADS AND ADAPTER WERE ABANDONED DUE REDUCE RISK OF INFECTION. NEW TRANSVENOUS SYSTEM WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8391116 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET INFECTION AND LEAD EROSION. ANTIBIOTICS WERE ADMINISTERED AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 8367599 ↗
• InjurySep 17, 2018Signal Artifact/Noise; High impedance; High Capture Threshold; Signal Artifact/Noise; High impedance; High Capture Threshold

  IT WAS REPORTED THAT HIGH THRESHOLDS, HIGH AND UNDEFINED IMPEDANCE AND NOISE WERE NOTED ON THE RIGHT ATRIAL (RA) LEADS. IT WAS NOTED THAT A PREVIOUSLY IMPLANTED ADAPTER WAS FIXED TO TWO RA LEADS AND AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). DURING THE CHANGE OUT OF THE ICD, THE LEADS WERE CAPPED AND REPLACED WITH ONE RA LEAD AND THE ADAPTER WAS REMOVED. WHEN DOING THE BATTERY CHANGE OF THE ICD THE PHYSICIAN TESTED THE TWO RA LEADS AND THRESHOLDS WERE WITHIN NORMAL LIMITS. THEREFORE IT WAS CONCLUDED THAT THE ADAPTER MAY BE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7883536 ↗
• InjuryApr 18, 2017Electrical /Electronic Property Problem; Connection Problem; Electrical /Electronic Property Problem; Connection Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED HIGH DEFIBRILLATION THRESHOLDS. APPROXIMATELY SIX MONTHS LATER A DEFIBRILLATION LEAD WAS IMPLANTED AND SEVENTEEN DEFIBRILLATION TESTS WERE PERFORMED. AFTER THE PATIENT RETURNED HOME, PRE-SYNCOPAL EPISODES WERE EXPERIENCED AND RE-PROGRAMMING WAS PERFORMED. THIS WAS FOLLOWED BY CHANGING THE SENSITIVITY. IT WAS LATER DETERMINED THE ADAPTOR WAS NOT FULLY INSERTED INTO THE RIGHT VENTRICULAR PACE/SENSE PORT ON THE DEVICE. THE ADAPTOR WAS DISCONNECTED FROM THE RV PORT AND RECONNECTED. THE CONNECTION WAS TESTED AND THE ADAPTOR REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope

  MAUDE report 6501099 ↗