WiSE CRT System 1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00859244007043), received between Jun 24, 2025 and Sep 25, 2026 — classified as 1 death, 6 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (11 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Human-Device Interface Problem

  Patient problems: Unspecified Heart Problem

  MAUDE report 50903688 ↗
• InjurySep 23, 2026Human-Device Interface Problem

  Patient problems: Unspecified Heart Problem

  MAUDE report 50876100 ↗
• MalfunctionSep 11, 2026Human-Device Interface Problem

  Patient problems: Unspecified Heart Problem

  MAUDE report 50741397 ↗
• InjuryJul 14, 2026Failure to Deliver

  IT WAS REPORTED THAT FOLLOWING RE-ESTABLISHMENT OF RETROAORTIC ACCESS, THE PHYSICIAN ELECTED TO RETURN TO THE ORIGINAL BASAL SEPTAL TARGET LOCATION. ACCORDING TO THE PROCEDURE REPORT, EBR PERSONNEL ADVISED THAT THE TARGET LOCATION REQUIRED EXTREME DELIVERY SHEATH DEFLECTION AND RECOMMENDED SELECTING AN ALTERNATIVE LOCATION REQUIRING LESS DEFLECTION. THE PHYSICIAN ELECTED TO PROCEED WITH THE ORIGINAL TARGET LOCATION. DURING NAVIGATION OF THE DELIVERY SYSTEM, PROGRESSIVE HYPOTENSION WAS NOTED BY ANESTHESIA. ECHOCARDIOGRAPHY REPORTEDLY DEMONSTRATED NO EVIDENCE OF PERICARDIAL EFFUSION. EBR PERSONNEL RECOMMENDED REMOVAL OF SHEATH DEFLECTION TO REDUCE POTENTIAL PRESSURE ON SURROUNDING STRUCTURES; HOWEVER, THE PROCEDURE CONTINUED. THE PATIENT'S BLOOD PRESSURE CONTINUED TO DECLINE, AND VENTRICULAR TACHYCARDIA WAS SUBSEQUENTLY OBSERVED, REQUIRING THREE EXTERNAL DEFIBRILLATION SHOCKS. SINUS RHYTHM WAS RESTORED, THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS TRANSFERRED TO THE ICU FOR MONITORING. PER SITE REPORT, THE PATIENT STABILIZED SHORTLY THEREAFTER. PLEASE SEE ASSOCIATED MDR# 3013596742-2026-.

  Patient problems: Unspecified Heart Problem

  MAUDE report 25820092 ↗
• MalfunctionJul 14, 2026Failure to Deliver

  IT WAS REPORTED THAT AN ELECTRODE WAS IMPLANTED AT A BASAL SEPTAL RIGHT VENTRICULAR LOCATION. PRE-ANCHOR MEASUREMENTS WERE ACCEPTABLE, THE ELECTRODE WAS SUCCESSFULLY ANCHORED, POST-ANCHOR THRESHOLD IMPROVED TO 0.8 V @ 0.5 MS, ANCHORING WAS CONFIRMED IN TWO FLUOROSCOPIC VIEWS, AND BOTH DETACHMENT INDICATORS WERE OBSERVED PRIOR TO RELEASE. IMMEDIATELY FOLLOWING RELEASE, THE ELECTRODE BECAME DISLODGED FROM THE IMPLANT SITE. REVIEW OF THE PROCEDURE INDICATED THE DISLODGEMENT MAY HAVE BEEN ASSOCIATED WITH INTERACTION BETWEEN THE DELIVERY SHEATH AND ELECTRODE DURING THE RELEASE PROCESS, POTENTIALLY DUE TO SIGNIFICANT TORQUE WITHIN THE DELIVERY SYSTEM RESULTING FROM MAXIMUM SHEATH DEFLECTION AND POSSIBLE INCOMPLETE DE-SHEATHING OF THE ELECTRODE PRIOR TO WITHDRAWAL OF THE DELIVERY CATHETER AND SHEATH. THE DISLODGED ELECTRODE WAS SUCCESSFULLY RETRIEVED USING A SNARE WITHOUT REPORTED PATIENT INJURY ATTRIBUTABLE TO THE DISLODGEMENT EVENT. PLEASE SEE ASSOCIATED MDR REPORT # 3013596742-2026-00057.

  Patient problems: Unspecified Heart Problem

  MAUDE report 25820087 ↗
• MalfunctionJul 2, 2026Human-Device Interface Problem

  IT WAS REPORTED THAT MULTIPLE ATTEMPTS WERE MADE TO PLACE THE ELECTRODE ON BOTH THE LATERAL AND SEPTAL WALLS; THESE ATTEMPTS RESULTED IN EITHER UNACCEPTABLE MEASUREMENTS OR INABILITY TO ACHIEVE PROPER ANCHORING. THE FINAL PLACEMENT ATTEMPT ON THE LATERAL WALL DEMONSTRATED OUT-OF-RANGE ANGLES BUT ACCEPTABLE THRESHOLD AND ANCHORING VIEWS. AFTER ANCHORING WAS INITIALLY CONFIRMED, WITHDRAWAL AND RE-ADVANCEMENT OF THE DELIVERY CATHETER REVEALED THAT THE ELECTRODE HAD BECOME UNANCHORED, APPEARING LODGED IN THE BASAL LATERAL WALL BENEATH THE MITRAL VALVE. THROUGHOUT THE PROCEDURE AND POST-PROCEDURE ASSESSMENT, RIGHT VENTRICULAR PACING DATA SHOWED INCONSISTENT TRACKING AND INTERMITTENT CAPTURE, WHICH WAS ALSO CONFIRMED DURING PACU EVALUATIONS. THE PATIENT WAS RETURNED TO THE LAB FOR AN ATTEMPTED SNARE RETRIEVAL OF THE ELECTRODE; HOWEVER, THIS WAS UNSUCCESSFUL. FOLLOWING RELEASE, CONSISTENT TRACKING COULD NOT BE ACHIEVED DESPITE ADHERENCE TO BEST-PRACTICE OPTIMIZATION PROTOCOLS, AND TRACKING LEVEL AND THRESHOLD COULD NOT BE DETERMINED. PERSISTENT LOW SIGNAL STRENGTH WAS OBSERVED THROUGHOUT THE PROCEDURE AND FOLLOW-UP DESPITE REPOSITIONING THE ANTENNA DIRECTLY AGAINST THE BATTERY POCKET IN M

  Patient problems: Unspecified Heart Problem

  MAUDE report 25693472 ↗
• DeathJun 23, 2026Use of Device Problem

  On (b)(6)2026, a patient who had undergone a successful Wise electrode implant procedure on (b)(6) 2026, experienced ventricular tachycardia (VT) that progressed to ventricular fibrillation (VF) during a routine transthoracic echocardiogram (TTE) examination in the ICU setting (1-day post-procedure). Despite prompt external defibrillation and prolonged resuscitative efforts, return of spontaneous circulation was not achieved and the patient expired.At the time of the event, the patient was undergoing TTE and was being monitored with a 12-lead electrocardiogram (ECG). Reported ECG recordings demonstrated one to two premature ventricular contractions (PVCs) preceding the onset of VT, subsequently degenerating into VF. There was no observed period of sustained high-rate pacing preceding the event; rather, isolated PVCs appeared to trigger the arrhythmia. The WiSE electrode implant procedure had been completed without reported complications on the prior day, and the TTE was reported to have been ordered and performed as part of routine clinical care per the treating physician.EBR has made multiple attempts to obtain additional information regarding this event from the implanting physic

  Patient problems: Unspecified Heart Problem

  MAUDE report 25602227 ↗
• InjuryJun 23, 2026Improper or Incorrect Procedure or Method

  ON (B)(6) 2026, A PATIENT WHO HAD UNDERGONE A SUCCESSFUL WISE ELECTRODE IMPLANT PROCEDURE ON (B)(6) 2026, EXPERIENCED VENTRICULAR TACHYCARDIA (VT) THAT PROGRESSED TO VENTRICULAR FIBRILLATION (VF) DURING A ROUTINE TRANSTHORACIC ECHOCARDIOGRAM (TTE) EXAMINATION IN THE ICU SETTING (1-DAY POST-PROCEDURE). THE PATIENT WAS SUCCESSFULLY TREATED BY A PREVIOUSLY IMPLANTED DEFIBRILLATOR, WHICH DELIVERED THERAPY AND RESTORED THE PATIENT TO A PACED RHYTHM. AT THE TIME OF THE EVENT, THE PATIENT WAS UNDERGOING TTE AND WAS BEING MONITORED WITH A 12-LEAD ELECTROCARDIOGRAM (ECG). REPORTED ECG RECORDINGS DEMONSTRATED ONE TO TWO PREMATURE VENTRICULAR CONTRACTIONS (PVCS) PRECEDING THE ONSET OF VT, SUBSEQUENTLY DEGENERATING INTO VF. THERE WAS NO OBSERVED PERIOD OF SUSTAINED HIGH-RATE PACING PRECEDING THE EVENT; RATHER, ISOLATED PVCS APPEARED TO TRIGGER THE ARRHYTHMIA. THE WISE ELECTRODE IMPLANT PROCEDURE HAD BEEN COMPLETED WITHOUT REPORTED COMPLICATIONS ON THE PRIOR DAY, AND THE TTE WAS REPORTED TO HAVE BEEN ORDERED AND PERFORMED AS PART OF ROUTINE CLINICAL CARE PER THE TREATING PHYSICIAN. EBR HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT FROM THE IMPLANTING PHYSICIAN

  Patient problems: Unspecified Heart Problem

  MAUDE report 25602221 ↗
• InjuryJun 15, 2026Human-Device Interface Problem

  IT WAS REPORTED THAT THE PROCEDURE INVOLVED MULTIPLE ATTEMPTS AT BOTH SEPTAL AND LATERAL WALL ELECTRODE POSITIONING. PRE-PROCEDURAL ASSESSMENT IDENTIFIED POTENTIAL LUNG ENCROACHMENT DURING MODERATE INHALATION, AND THE ASSOCIATED RISKS, INCLUDING REDUCED BIVENTRICULAR PACING AND POTENTIAL INABILITY TO MAINTAIN ELECTRODE TRACKING, WERE DISCUSSED WITH THE PHYSICIAN. GIVEN THE PATIENT'S LIMITED THERAPEUTIC OPTIONS, THE PHYSICIAN ELECTED TO PROCEED, AND A COORDINATED PLAN WITH ANESTHESIA WAS IMPLEMENTED TO UTILIZE BREATH HOLDS AND REDUCED TIDAL VOLUME DURING ELECTRODE POSITIONING AS NEEDED. INITIAL SEPTAL POSITIONING ATTEMPTS DEMONSTRATED ADEQUATE WALL SEAL; HOWEVER, ELECTRODE TRACKING WAS INTERMITTENTLY LOST AND IMPROVED ONLY WITH RESPIRATION HOLD. DESPITE ACCEPTABLE POSITIONING MEASUREMENTS, NO CAPTURE WAS ACHIEVED AT 4.0 V DURING MULTIPLE SEPTAL ATTEMPTS. A SUBSEQUENT SEPTAL ANCHORING ATTEMPT DEMONSTRATED A FAVORABLE PRE-ANCHOR THRESHOLD WITH CONFIRMED ANCHORING; HOWEVER, POST-ANCHOR THRESHOLDS PROGRESSIVELY INCREASED IN THE ABSENCE OF CURRENT OF INJURY, LEADING TO ELECTIVE DE-ANCHORING. A LATERAL WALL ATTEMPT THEN DEMONSTRATED IMPROVING THRESHOLDS AND SUCCESSFUL ANCHORING WITH ACCEP

  Patient problems: Unspecified Heart Problem

  MAUDE report 25512278 ↗
• MalfunctionMay 29, 2026Failure to Capture; Human-Device Interface Problem

  IT WAS REPORTED "THE PATIENT DEMONSTRATED CONSISTENT RV PACE DETECTION; HOWEVER, NO TRACKING OR BIV CAPTURE WAS OBSERVED. THE PATIENT CAME IN WITH REDUCED TRACKING, AND ALL STEPS OUTLINED IN THE BEST-PRACTICE FOLLOW-UP FLOWCHART WERE PERFORMED IN AN ATTEMPT TO OPTIMIZE TRACKING, BUT TRACKING COULD NOT BE ACHIEVED". ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT HAD 88% TRACKING AT THE PRIOR 1 MONTH VISIT , WITH NO TRACKING ISSUES NOTED AT THAT TIME. DEVICE THRESHOLDS WERE WITHIN EXPECTED RANGES (1.5 SUPINE, 5.0 SITTING, 2.5 STANDING), WITH NO PROGRAMMER ALERTS, WARNINGS, COMMUNICATION ERRORS, OR ABNORMAL SYSTEM MESSAGES IDENTIFIED DURING INTERROGATION. SUBSEQUENT EVALUATION REVEALED INCONSISTENT TRACKING ACROSS MULTIPLE POSITIONS AND BREATHING MANEUVERS. R V PACE DETECTION REMAINED STABLE (79 TO 84 DETECTIONS PER MINUTE) THROUGHOUT INTERROGATION. RV RETRAINING WAS ATTEMPTED WITHOUT LASTING EFFECT. EXAMINATION OF THE DEVICE POCKET SHOWED NO EVIDENCE OF ROTATION, HEMATOMA, FLUID ACCUMULATION, OR MIGRATION. NO IMAGING SUCH AS CHEST X-RAY OR FLUOROSCOPY HAD BEEN PERFORMED AT THE TIME OF REPORTING. THE PHYSICIAN DID NOT DETERMINE A CAUSE FOR THE REDUCED TRACKING OR DECREASED BI V

  Patient problems: Unspecified Heart Problem

  MAUDE report 25340356 ↗
• MalfunctionMay 27, 2026Human-Device Interface Problem

  IT WAS REPORTED THAT "DURING A FOLLOW-UP VISIT INCREASED WISE CAPTURE THRESHOLDS NECESSITATED REPROGRAMMING THE DEVICE TO HIGHER OUTPUT SETTINGS, RESULTING IN A SIGNIFICANT REDUCTION IN PROJECTED BATTERY LONGEVITY". ADDITIONAL INFORMATION STATES THAT DURING THE FOLLOW-UP APPOINTMENT IT WAS CONFIRMED THAT THE PATIENT'S INCREASED PACING THRESHOLDS WERE CONSISTENT ACROSS MULTIPLE CHECKS AND BODY POSITIONS. DESPITE A REPORTED 99% BIV TRACKING, EKG RESULTS SHOWED NO MORPHOLOGY CHANGES, INDICATING THAT THE ISSUE WAS RELATED TO LV CAPTURE RATHER THAN TRACKING. DEVICE EVALUATIONS FOUND NO EVIDENCE OF ELECTRODE MIGRATION, TRANSMITTER MOVEMENT, TELEMETRY ISSUES, OR ABNORMAL DEVICE BEHAVIOR, WITH STABLE DISTANCE AND ANGLE MEASUREMENTS COMPARED TO PRIOR VISITS. BATTERY PERFORMANCE WAS NORMAL ASIDE FROM THE HIGHER OUTPUT REQUIRED DUE TO INCREASED THRESHOLDS, AND RV PACING DETECTION WAS FUNCTIONING CORRECTLY. THE PHYSICIAN DID NOT IDENTIFY A CLEAR CAUSE BUT SUSPECTED SUBOPTIMAL THERAPY DELIVERY AS A REASON FOR THE PATIENT'S LACK OF SYMPTOMATIC IMPROVEMENT. AS A RESULT, THE PATIENT WAS PROGRAMMED AT THRESHOLD SETTINGS AND SCHEDULED FOR A FOLLOW-UP IN ONE MONTH TO REASSESS SYMPTOM IMPROVEMENT VERS

  Patient problems: Unspecified Heart Problem

  MAUDE report 25301529 ↗
• MalfunctionMay 19, 2026Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THERE WAS AN INADVERTENT DETACHMENT OF AN ELECTRODE UNRELATED TO ANCHORING OR EMBOLIZATION. ADDITIONAL INFORMATION STATES THAT DURING THE PROCEDURE, AN ELECTRODE DETACHED AND WAS OBSERVED FLOATING IN THE LEFT VENTRICLE (LV), DESPITE HAVING BEEN CONFIRMED SECURELY ATTACHED TO THE CATHETER PRIOR TO REINSERTION. NO ABNORMALITIES WERE FOUND IN THE ELECTRODE SYSTEM, INCLUDING THE CATHETER, DELIVERY SHEATH, INSERTION TOOL, OR HEMOSTATIC VALVE, AND NO AIR BUBBLES WERE DETECTED. THE EXACT CAUSE OF THE DETACHMENT IS UNKNOWN, BUT IT MAY BE RELATED TO IMPROPER POSITIONING OF THE INSERTION TOOL OR VALVE, AS WELL AS KINKING OF THE TRANSEPTAL SHEATH, WHICH OCCURRED BOTH ABOVE THE TRANSMITTER AND DURING RETRIEVAL. THE PHYSICIAN ACKNOWLEDGED DETACHING THE ELECTRODE WHILE THE BALLOON WAS NOT IN THE RECOMMENDED POSITION. THE ELECTRODE WAS SUCCESSFULLY RETRIEVED IN TWO ATTEMPTS, TAKING APPROXIMATELY 10 MINUTES AND 30 MINUTES RESPECTIVELY, WITH INTERVENTIONAL RADIOLOGY CONSULTED FOR SUPPORT. THE PATIENT WAS MONITORED IN THE HOSPITAL FOR TWO DAYS, WITH FOLLOW-UP CHECKS SHOWING STABLE ELECTRODE POSITIONING, CONSISTENT TRACKING, AND EFFECTIVE BIV PACING. NO HEMOD

  Patient problems: Unspecified Heart Problem

  MAUDE report 25220142 ↗
• MalfunctionMay 11, 2026Pacing Inadequately

  IT WAS REPORTED THAT DURING A 4-MONTH FOLLOW-UP VISIT ON (B)(6) 2026, THE WISE CRT SYSTEM DEMONSTRATED INTERMITTENT AND POSTURE-DEPENDENT LOSS OF TRACKING RESULTING IN REDUCED BIVENTRICULAR (BIV) PACING. HISTORICAL DEVICE DATA SHOWED BIV TRACKING PERCENTAGE HAD DECLINED FROM 87% IN (B)(6) 2026 TO 47% IN (B)(6) 2026 AND 37% AT THE CURRENT FOLLOW-UP VISIT. DURING IN-CLINIC TESTING, NO TRACKING OR BIV CAPTURE WAS OBSERVED IN SUPINE OR SITTING POSITIONS DURING NORMAL RESPIRATION. TRACKING AND CAPTURE COULD ONLY BE ACHIEVED WHEN THE PATIENT FULLY EXHALED. TROUBLESHOOTING AND OPTIMIZATION WERE PERFORMED, INCLUDING THRESHOLD TESTING AND PROGRAMMING ADJUSTMENTS. FINAL PROGRAMMING WAS CHANGED TO RV SYNCHRONOUS MODE AT TL 5.0 @ PW 0.3 MS TO MAINTAIN THERAPY DELIVERY WHILE CONSERVING BATTERY LONGEVITY. NO ADVERSE PATIENT SEQUELAE WERE REPORTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 25145076 ↗
• MalfunctionMay 11, 2026Failure to Capture

  IT WAS REPORTED THAT DURING A 6-WEEK FOLLOW-UP VISIT ON (B)(6) 2026, THE WISE CRT SYSTEM DEMONSTRATED CONSISTENT RV PACE DETECTION AND CONSISTENT ELECTRODE TRACKING; HOWEVER, NO BIVENTRICULAR (BIV) CAPTURE WAS OBSERVED ON 12-LEAD ECG IN SUPINE OR SITTING POSITIONS DESPITE MAXIMUM OUTPUT PROGRAMMING AT TL 6.0 @ 4.4 MS. THE PATIENT WAS UNABLE TO UNDERGO STANDING POSITIONAL TESTING DUE TO BLOOD PRESSURE ISSUES AND A HISTORY OF STROKE WITH NEUROLOGICAL DISTRESS. DEVICE INTERROGATION SHOWED APPROXIMATELY 95% TRACKING WITH EDGES PER RV OF 1.057 AND A MEAN ELECTRODE DISTANCE OF 12.3 CM. BATTERY VOLTAGE WAS 2.87 V WITH REDUCED PROJECTED LONGEVITY ATTRIBUTED TO SUSTAINED HIGH-OUTPUT THERAPY REQUIREMENTS. THRESHOLD TESTING COULD NOT BE COMPLETED BECAUSE CAPTURE WAS NOT ACHIEVED IN TESTED POSITIONS. THE SYSTEM REMAINED PROGRAMMED AT MAXIMUM OUTPUT SETTINGS IN RV SYNCHRONOUS MODE. NO ADVERSE PATIENT SEQUELAE WERE REPORTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 25144924 ↗
• MalfunctionMay 11, 2026Communication or Transmission Problem

  IT WAS REPORTED DURING A FOLLOW-UP VISIT ON (B)(6) 2026, THE WISE CRT SYSTEM DEMONSTRATED INTERMITTENT MISSED TRACKING EVENTS DURING IN-CLINIC TESTING. THE PATIENT WAS UNABLE TO STAND OR LIE FLAT; THEREFORE, TESTING WAS PERFORMED IN A MODIFIED SITTING/SUPINE POSITION BASED ON THE PATIENT'S SLEEPING POSTURE. THE CO-IMPLANTED ABBOTT AVEIR DR DEVICE WAS PROGRAMMED IN AAI/VVI MODE, AND PER PHYSICIAN REQUEST, EVALUATION WAS ALSO PERFORMED IN VDD MODE. DURING VDD MODE TESTING, THE WISE CRT SYSTEM REPORTEDLY COULD NOT APPROPRIATELY TRACK OR DETECT PACING ACTIVITY. DEVICE INTERROGATION DEMONSTRATED STABLE SYSTEM METRICS INCLUDING 2.96V BATTERY VOLTAGE, 98% REMAINING CAPACITY, NORMAL BATTERY CURVE, AND 84% BIV PACING WITH 57 RV PACING SPIKES BELOW 140 BPM. ALTHOUGH STORED DATA DEMONSTRATED 84% TRACKING, INTERMITTENT MISSED TRACKING EVENTS WERE OBSERVED DURING LIVE TESTING. NO PATIENT SEQUALAE WERE REPORTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 25144436 ↗
• MalfunctionMay 11, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT AN INITIAL WISE CRT SYSTEM IMPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2026 AT UNIVERSITY OF (B)(6) HOSPITAL. DURING THE PROCEDURE, DIFFICULT IMAGING CONDITIONS ASSOCIATED WITH A REPROCESSED ICE CATHETER AND SUBOPTIMAL CINE IMAGING WERE ENCOUNTERED. CARTO MAPPING IDENTIFIED THE LATERAL WALL AS THE ONLY SUITABLE IMPLANT LOCATION DUE TO NON-EXISTENT SEPTAL ACTIVATION. FOLLOWING ELECTRODE RELEASE, INTERMITTENT ELECTRODE TRACKING AND INTERMITTENT BIVENTRICULAR (BIV) PACING WERE OBSERVED. ADDITIONAL INFORMATION RECEIVED ON 08-MAY-2026 INDICATED THAT INCONSISTENT TRACKING PERSISTED DURING A PRE-DISCHARGE FOLLOW-UP VISIT ON (B)(6) 2026. THRESHOLD TESTING DEMONSTRATED CAPTURE AT TL 6.0 @ 2.0 MS IN SUPINE AND SITTING POSITIONS; HOWEVER, THE SYSTEM REMAINED PROGRAMMED AT MAXIMUM OUTPUT SETTINGS OF TL 6.0 @ PW 4.4 MS DUE TO INCONSISTENT TRACKING AND ELEVATED THRESHOLDS. DEVICE INTERROGATION SHOWED NORMAL BATTERY STATUS AND BATTERY CURVE, BUT PROJECTED RRT AND EOS DATES WERE REDUCED DUE TO SUSTAINED HIGH-OUTPUT REQUIREMENTS. INTERMITTENT BIV PACING PERSISTED POST-OPERATIVELY, ALTHOUGH QRS NARROWING DURING BIV PACING CONFIRMED INTERMITTENT THERAPEUTIC CAPTURE. NO ADVERSE PATI

  Patient problems: Unspecified Heart Problem

  MAUDE report 25143986 ↗
• MalfunctionMay 7, 2026Communication or Transmission Problem

  DURING AN INITIAL IMPLANT PROCEDURE ON (B)(6) 2026, INCONSISTENT ELECTRODE TRACKING AND INABILITY TO MAINTAIN CONSISTENT BIVENTRICULAR (BIV) PACING WERE OBSERVED FOLLOWING ELECTRODE RELEASE AND DURING POST-OPERATIVE ASSESSMENT. PRE-ANCHOR THRESHOLD TESTING MEASURED 1.6 V @ 0.5 MS AND POST-ANCHOR THRESHOLD TESTING MEASURED 1.0 V @ 0.5 MS; HOWEVER, POST-RELEASE THRESHOLD TESTING COULD NOT BE COMPLETED DUE TO LIMITED TRACKING. WISE BIV QRS DURATION COULD NOT BE OBTAINED DUE TO INCONSISTENT TRACKING AND INABILITY TO MAINTAIN STABLE BIV PACING. DEVICE PROGRAMMING WAS ADJUSTED TO MAXIMUM OUTPUT SETTINGS (TL 6.0 @ 1.0 MS) IN AN ATTEMPT TO OPTIMIZE THERAPY DELIVERY. THE PATIENT WAS SCHEDULED FOR FOLLOW-UP EVALUATION WITHIN ONE WEEK. NO ADVERSE PATIENT SEQUELAE WERE REPORTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 25119410 ↗
• MalfunctionMay 6, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT DURING AN INITIAL IMPLANT PROCEDURE PERFORMED ON (B)(6) 2026, BIVENTRICULAR (BIV) PACING COULD NOT BE ESTABLISHED INTRAOPERATIVELY FOLLOWING ELECTRODE RELEASE. THE PATIENT WAS SUBSEQUENTLY MONITORED POST-OPERATIVELY, WHERE INTERMITTENT ELECTRODE TRACKING AND INTERMITTENT BIV PACING WERE OBSERVED. POST-ANCHOR THRESHOLD TESTING MEASURED 1.7 V AT 0.5 MS; HOWEVER, COMPLETE WISE THRESHOLD TESTING COULD NOT BE PERFORMED DUE TO INTERMITTENT TRACKING AND INTERMITTENT BIV PACING. QRS MEASUREMENTS DOCUMENTED AN RV-ONLY QRS DURATION OF 190 MS AND A WISE BIV QRS DURATION OF 135 MS WHEN INTERMITTENT BIV PACING WAS ACHIEVED. NO ADVERSE PATIENT SEQUELAE WERE REPORTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 25107604 ↗
• MalfunctionMay 5, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT A SINGLE-STAGE IMPLANT OF THE WISE CRT SYSTEM WAS PERFORMED. FOLLOWING ELECTRODE RELEASE, CONSISTENT ELECTRODE TRACKING COULD NOT BE ACHIEVED INTRAOPERATIVELY OR DURING THE IMMEDIATE POST-OPERATIVE PERIOD. AS A RESULT, EFFECTIVE AND SUSTAINED WISE BIVENTRICULAR PACING COULD NOT BE CONSISTENTLY CONFIRMED, AND WISE BIV QRS DURATION MEASUREMENTS WERE NOT OBTAINED DUE TO LIMITED TRACKING. THE PATIENT IS SCHEDULED FOR FOLLOW-UP FOR FURTHER EVALUATION AND TROUBLESHOOTING OF THE TRACKING ISSUE. NO ADVERSE PATIENT SEQUELAE WERE REPORTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 25089326 ↗
• MalfunctionApr 27, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A WISE CRT SYSTEM IMPLANT PROCEDURE, TWO ELECTRODE IMPLANTATION ATTEMPTS WERE MADE; HOWEVER, NEITHER ELECTRODE WAS SUCCESSFULLY IMPLANTED AS BOTH FAILED TO ACHIEVE TRACKING. TROUBLESHOOTING WAS PERFORMED DURING THE PROCEDURE, INCLUDING ASSESSMENT OF POTENTIAL NOISE SOURCES AND OPTIMIZATION OF CO-IMPLANT PROGRAMMING IN ACCORDANCE WITH BEST PRACTICES; HOWEVER, TRACKING COULD NOT BE ESTABLISHED. AS A RESULT, THE PROCEDURE WAS ABANDONED WITHOUT ELECTRODE IMPLANTATION. THE PHYSICIAN PLANS TO BRING THE PATIENT BACK AT A LATER DATE TO REATTEMPT THE PROCEDURE IN A DIFFERENT ROOM. NO ADVERSE PATIENT SEQUELAE WERE REPORTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 25006337 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, DURING A WISE CRT SYSTEM ELECTRODE IMPLANTATION PROCEDURE AT MUSC, A PROCEDURAL COMPLICATION INVOLVING PERICARDIAL EFFUSION REQUIRING SURGICAL INTERVENTION OCCURRED. THE PROCEDURE WAS STAGED, WITH THE BATTERY (MODEL 3100) AND TRANSMITTER (MODEL 4100) PREVIOUSLY IMPLANTED ON (B)(6) 2026. A CO-IMPLANT ABBOTT AVEIR VR LEADLESS PACEMAKER WAS PROGRAMMED IN VVI MODE. DURING ELECTRODE IMPLANTATION, MULTIPLE TARGET LOCATIONS WERE EVALUATED. AT THE SECOND LOCATION (MID LATERAL WALL), CONTRAST WAS INJECTED WITH EXCESSIVE FORCE THROUGH THE MANIFOLD, RESULTING IN VISIBLE MYOCARDIAL STAINING AND SUSPECTED TISSUE DISSECTION, CONFIRMED BY FLUOROSCOPY AND INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE SITE WAS ABANDONED. SUBSEQUENT POSITIONING ATTEMPTS WERE MADE. AT THE FOURTH LOCATION, ACCEPTABLE PRE-ANCHOR MEASUREMENTS WERE OBTAINED (DISTANCE 10.2 CM, ANGLE 30°, R-WAVE 5 MV, THRESHOLD 2.3V @ 0.5 MS, QLV 70 MS). DURING OR IMMEDIATELY FOLLOWING ANCHORING, PERICARDIAL EFFUSION WAS IDENTIFIED ON ICE. THE ELECTRODE WAS DEPLOYED AT APPROXIMATELY 11:34 AM WHILE THE CLINICAL TEAM PREPARED FOR INTERVENTION. FOLLOWING DEPLOYMENT, VENTRICULAR TACHYCARDIA OCCURRED, AND PACING/

  Patient problems: Unspecified Heart Problem

  MAUDE report 24974800 ↗
• MalfunctionApr 22, 2026No Apparent Adverse Event

  IT WAS REPORTED AT A 6-MONTH FOLLOW-UP VISIT ON (B)(6), 2026, THAT A PATIENT IMPLANTED WITH THE WISE CRT SYSTEM EXPERIENCED WORSENING HEART FAILURE SYMPTOMS. THE PATIENT HAD RECEIVED AN INAPPROPRIATE SHOCK FROM THEIR SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) ON (B)(6), 2026, AND SYMPTOMS WERE REPORTED TO HAVE BEGUN FOLLOWING THAT EVENT. DEVICE INTERROGATION DEMONSTRATED THAT THE WISE CRT SYSTEM WAS OPERATING AS INTENDED. BATTERY VOLTAGE, REMAINING CAPACITY, AND DEPLETION PROFILE WERE WITHIN EXPECTED RANGES. BIVENTRICULAR (BIV) TRACKING WAS 96%, AND ACOUSTIC PARAMETERS (INCLUDING EDGES PER RV, DISTANCE, ANGLE, AND SENSOR PERFORMANCE) WERE WITHIN EXPECTED LIMITS. TESTING CONFIRMED EFFECTIVE BIV CAPTURE WITH OBSERVABLE TRANSITION ON EKG FROM RIGHT VENTRICULAR PACING TO BIV PACING. AN INCREASE IN PACING THRESHOLDS WAS OBSERVED COMPARED TO THE TWO-WEEK POST-OPERATIVE FOLLOW-UP. THE SYSTEM WAS REPROGRAMMED TO HIGHER OUTPUT SETTINGS TO MAINTAIN EFFECTIVE CAPTURE. THE CAUSE OF THE INCREASED THRESHOLDS IS UNKNOWN AT THIS TIME. ADDITIONAL CLINICAL EVALUATION, INCLUDING LAB WORK, HAS BEEN ORDERED. NO ADVERSE PATIENT SEQUELAE ATTRIBUTABLE TO THE WISE CRT SYSTEM HAVE BEEN REPO

  Patient problems: Unspecified Heart Problem

  MAUDE report 24961105 ↗
• MalfunctionApr 22, 2026Pacing Inadequately

  IT WAS REPORTED DURING A ROUTINE 4-YEAR FOLLOW-UP ON (B)(6) 2026, THAT A PATIENT IMPLANTED WITH THE WISE CRT SYSTEM EXHIBITED REDUCED BIVENTRICULAR (BIV) PACING PERFORMANCE. SINCE THE PREVIOUS FOLLOW-UP ON (B)(6) 2025, BIV PACING HAS DECREASED TO APPROXIMATELY 33%. LIMITED ELECTRODE TRACKING WAS OBSERVED ACROSS ALL POSTURES, WITH INTERMITTENT TRACKING AND BIV CAPTURE ACHIEVED ONLY IN THE SITTING POSITION. THE PATIENT WAS ALSO REPORTED TO HAVE EXPERIENCED SIGNIFICANT WEIGHT LOSS SINCE THE TIME OF THE INITIAL IMPLANT. SYSTEM DIAGNOSTICS, INCLUDING BATTERY VOLTAGE, REMAINING CAPACITY, AND ACOUSTIC PARAMETERS (E.G., EDGES PER RV, DISTANCE, AND ANGLE), WERE WITHIN EXPECTED RANGES. THE BATTERY DEPLETION PROFILE WAS CONSISTENT WITH NORMAL USE AND INDICATED PROGRESSION TOWARD ELECTIVE REPLACEMENT TIMELINES (RRT/EOS). NO DEVICE ALERTS OR MALFUNCTIONS WERE IDENTIFIED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 24960788 ↗
• MalfunctionApr 17, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, BIVENTRICULAR (BIV) PACING WAS COMPLETELY ABSENT ON THE TABLE FOLLOWING ELECTRODE DEPLOYMENT. EXTENSIVE INTRA-PROCEDURAL TROUBLESHOOTING WAS PERFORMED IN ACCORDANCE WITH BEST PRACTICE GUIDANCE, INCLUDING EVALUATION FOR NOISE, ADJUSTMENTS TO TRANSMIT LEVEL (TL) AND PULSE WIDTH, GLOBAL SEARCH CENTER OPTIMIZATION, SENSOR TESTING, PATIENT REPOSITIONING, BREATH-HOLD MANEUVERS, AND POCKET MANIPULATION. DESPITE THESE EFFORTS, NO TRACKING WAS ACHIEVED WITH ANY SENSOR EXCEPT THE VERTICAL SENSOR, WHICH DEMONSTRATED CONSISTENT TRACKING WHEN ENABLED. EDGE MEASUREMENTS REMAINED STABLE AT 1.000 THROUGHOUT, WITH NO INDICATION OF NOISE, AND RV PACE DETECTION WAS CONSISTENT WITH NO CO-IMPLANT SENSING ISSUES. ACOUSTIC WINDOW LIMITATIONS WERE SUSPECTED, SPECIFICALLY POTENTIAL AIR IN THE TRANSMITTER POCKET. NO ADDITIONAL PROGRAMMING CHANGES WERE REQUIRED POST-OPERATIVELY BEYOND RESTRICTING SENSING TO THE VERTICAL SENSOR, AND CONSISTENT BIV PACING WAS SUBSEQUENTLY OBSERVED POST-OP.NO ADVERSE PATIENT SEQUELAE WAS REPORTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 24918629 ↗
• MalfunctionMar 30, 2026Communication or Transmission Problem

  DURING A FOLLOW-UP VISIT ON (B)(6) 2026, INTERROGATION OF THE WISE CRT SYSTEM DEMONSTRATED APPROPRIATE RV PACE DETECTION; HOWEVER, NO ELECTRODE TRACKING WAS OBSERVED. BIV PACING SINCE IMPLANT WAS REPORTED AS (B)(4). MULTIPLE TROUBLESHOOTING AND PROGRAMMING ASSESSMENTS WERE PERFORMED FOR OVER ONE HOUR, INCLUDING EVALUATION OF SYSTEM PARAMETERS AND PATIENT POSTURE, BUT ELECTRODE TRACKING AND BIV PACING COULD NOT BE ACHIEVED. EDGE COUNTS INITIALLY REPORTED SINCE IMPLANT WERE ELEVATED; HOWEVER, ACUTE EDGE COUNTS DURING THE EVALUATION WERE NEAR 1 AND DID NOT APPEAR TO AFFECT RV PACE DETECTION. DEVICE DIAGNOSTICS SHOWED NORMAL BATTERY STATUS AND APPROPRIATE SYSTEM MEASUREMENTS. CHEST X-RAYS WERE REQUESTED TO FURTHER ASSESS THE POSITIONING AND STATUS OF THE SYSTEM COMPONENTS. NO ADVERSE PATIENT SEQUELAE WERE REPORTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 24736891 ↗