BIS/IS-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00836559002680), received between Jan 25, 2017 and May 2, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FEVER, REDNESS AND SWELLING DUE TO AN IDIOPATHIC INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) AND ADAPTOR WERE EXPLANTED FULLY WITHOUT REPLACEMENT AND THE LEADS WERE CUT AND PARTIALLY REMOVED WITHOUT REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 21950441 ↗
• MalfunctionApr 16, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED APPROXIMATELY FOUR WEEKS POST IMPLANT THAT BOTH EPICARDIAL RIGHT VENTRICULAR (RV) LEADS EXHIBITED HIGH THRESHOLDS AND BLOOD INSIDE THE LEADS. THE EPICARDIAL RV LEADS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PRODUCT WAS USED FOR AN EPICARDIAL PACEMAKER IMPLANTATION. THEN, THE SECOND PROCEDURE WAS A REVISION/ADDITION OF NEW EPICARDIAL ELECTRODES DUE TO HIGH THRESHOLDS ON THE LEADS. IT IS UNKNOWN WHICH LEADS THE ADAPTOR WAS ATTACHED TO. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. BLOOD WAS FOUND IN LEADS UPON EXPOSURE DURING REVISION PROCEDURE- ASSUMED BLOOD IN LEADS FROM USE IN BODY. THERE WAS NO BLOOD LOSS ASSOCIATED WITH BLOOD IN THE LEADS. NO LEAKAGE OBSERVED DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119148 ↗
• MalfunctionMar 29, 2024Extracardiac stimulation; Extracardiac stimulation

  IT WAS REPORTED THAT POST IMPLANT OF A GENERATOR CHANGE, THE PATIENT EXPERIENCED RECTUS ABDOMINUS MUSCLE STIMULATION. PROVOCATIVE TESTING WAS PERFORMED VIA A PACING SYSTEM ANALYZER (PSA) ON THE RIGHT VENTRICULAR (RV) LEADS AND THE ADAPTOR. WHEN THE LEADS WERE ADAPTED RECTUS MUSCLE STIMULATION PERSISTED UNTIL ADAPTOR WAS FULLY OUT OF THE POCKET. THE ADAPTOR WAS REMOVED AND REPLACED AND EXTRACARDIAC STIMULATION WAS FAINT, BUT STILL PRESENT. MEDICAL ADHESIVE WAS USED TO COVER THE SCREWS ON THE ADAPTOR AND THE ELECTRICALS WERE CHECKED THROUGH THE PSA AND NO EXTRACARDIAC STIMULATION PERSISTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY THE SAME DAY THAT IT TOOK PLACE.

  Patient problems: Heart Block

  MAUDE report 19006445 ↗
• MalfunctionMay 16, 2022Failure to Capture; Device Sensing Problem; Adverse Event Without Identified Device or Use Problem; Failure to Capture; Device Sensing Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS NO CAPTURE AT MAXIMUM OUTPUT (7.5V @ 1.5MS) AND THE ONLY SENSED R WAVES WERE FROM THE EXTERNAL PACEMAKER. DURING THE IMPLANTABLE ICD INTERROGATION, WE TURNED OFF THE EXTERNAL PACER IN ORDER TO ASCERTAIN THE UNDERLYING RHYTHM, AND IT WAS DISCOVERED THE PATIENT'S RHYTHM WAS COMPLETE HEART BLOCK. THE DOCTOR THEN TURNED THE EXTERNAL PACER BACK ON TO MAINTAIN CAPTURE. SUBSEQUENTLY, HE SUCCESSFULLY INSERTED A TEMPORARY TRANSVENOUS WIRE AND CONNECTED IT TO THE EXTERNAL TEMPORARY PACEMAKER, WHERE CONSTANT CAPTURE WAS TAKING PLACE. PATIENT OUTCOME IS STABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407179 ↗
• MalfunctionDec 13, 2021Over-Sensing; Device Sensing Problem; High Capture Threshold; Over-Sensing; Device Sensing Problem; High Capture Threshold

  IT WAS REPORTED RIGHT VENTRICULAR (RV) LEAD IN LEFT VENTRICULAR (LR) PORT 2 5071 ADAPTED INTO BIPOLAR CONFIG HAD CHRONIC HIGH THRESHOLDS AND POOR SENSING. LV LEAD IN RV PORT 4968 HAD OVERSENSING IN BIPOLAR AND PAUSE WAS OBSERVED ON HOLTER WITH REPRODUCIBLE OVERSENSING WITH ISOMETRICS AND MOVEMENT. REPROGRAMMED TO UNI WITH 4 MV SENSITIVITY AND RESOLVED SOME OF THE OVERSENSING AND INHIBITION. REVISION/NEW CASE SCHEDULED. DISCUSSED EXTRACTION NOT RECOMMENDED ON EPI LEADS. REFERRED TO OMA IF DOCTOR WOULD LIKE TO DISCUSS EXTRACTION FURTHER. DISCUSSED POSSIBLE CONFIGURATION OPTIONS TO TRY AND GET BETTER SENSING. CONSIDER SWITCHING LEADS BACK TO PORT WHERE THEY ARE PLACED AND TESTING MULTIPLE CONFIGURATIONS. PATIENT IS PACER DEPENDENT. THE ADAPTOR REMAINS IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12982817 ↗
• InjuryAug 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED "COMPLETE SYSTEM EXTRACTED DUE TO INFECTION.". DEVICE/LEAD SNS (B)(4) WERE REMOVED ON (B)(6) 2018.

  Patient problems: Unspecified Infection

  MAUDE report 7786723 ↗
• InjuryApr 24, 2018High Sensing Threshold; High Sensing Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS. THE PATIENT EXPERIENCED RECURRENCE OF DIZZINESS AND NEAR SYNCOPE LAST MONTH. THE RV CAPTURE THRESHOLDS WERE INCREASED TO THE HIGHEST OUTPUTS, WHICH RESOLVED THE SYMPTOMS. IT WAS NOTED THAT THE PATIENT CONTINUES TO EXPERIENCE OCCASIONAL PALPITATIONS AND SQUEEZING CHEST PAIN. DURING THE PROCEDURE, TWO LEFT VENTRICULAR (LV) LEADS WERE ATTEMPTED, BUT NOT USED DUE TO NO SUPERIOR CAPTURE THRESHOLD AND IN MOST LOCATIONS NO CAPTURE AT ALL. THE PHYSICIAN DECIDED TO USE THE ALTERNATIVE RV EPICARDIAL LEAD, WITH STABLE THRESHOLDS TO GIVE THE PATIENT MORE THAN FIVE YEARS OF PACING. THE LEAD IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED.

  Patient problems: Chest Pain; Dizziness; Palpitations; Syncope

  MAUDE report 7453888 ↗
• InjuryJan 25, 2017Electrical /Electronic Property Problem; Low impedance; High Capture Threshold; Electrical /Electronic Property Problem; Low impedance; High Capture Threshold

  IT WAS REPORTED THAT AN ELECTRICAL SHORT IN THE LEAD ADAPTOR WAS CAUSING DIAPHRAGMATIC AND NERVE STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. HIGH THRESHOLDS AND LOW IMPEDANCE WERE ALSO OBSERVED. THE ADAPTOR WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. HOSPITAL: (B)(6).

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 6275604 ↗