MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE? EL ICD VR; Implantable Cardioverter Defibrillator (Non-Crt)

Model Number	D432
Medical Device Problem Codes	Failure to Capture (1081); Pacing Problem (1439); Device Sensing Problem (2917); High Capture Threshold (3266)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	06/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.This investigation will be updated should pertinent information become available in the future.
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) exhibited a heart rate of 30 beats per minute (bpm).Technical services (ts) was consulted and , upon data review , discussed that the heart rate was below the device's lower rate limit.Intermittent high capture thresholds were noted, and the right ventricular automatic threshold (rvat) test detected as greater than programmed amplitude or suspended.Further rv lead evaluation was recommended.This device remains in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) exhibited a heart rate of 30 beats per minute (bpm).Technical services (ts) was consulted and , upon data review , discussed that the heart rate was below the device's lower rate limit.Intermittent high capture thresholds were noted, and the right ventricular automatic threshold (rvat) test detected as greater than programmed amplitude or suspended.Further rv lead evaluation was recommended.This device remains in service.No additional adverse patient effects were reported.Additional information was received.The local sales representative checked the patient and confirmed the thresholds were high at 1.4v @.4ms with an output of 2.0v@.4ms.While loss of capture was not confirmed, it was determined that the pacing outputs were not high enough to provide an adequate safety margin and the patient's heart rates were in the 30 bpm range.The patient passed away the next day; however, the clinic did not provide the official cause of death to the sales representative.With no further information available, boston scientific cannot rule out a device or rv lead issue as a contributing factor in the patient's death.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: RESONATE? EL ICD VR
• Common Device Name: Implantable Cardioverter Defibrillator (Non-Crt)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 25860567
• Report Number: 2124215-2026-38513
• Device Sequence Number: 5470940
• Product Code: LWS
• UDI-Device Identifier: 00802526588044
• UDI-Public: (01)00802526588044(17)210902
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/02/2021
• Device Model Number: D432
• Device Catalogue Number: D432
• Device Lot Number: 259361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Supplement Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 07/17/2026
• Supplement Report FDA Received Date: 08/17/2026
• Date Device Manufactured: 09/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization
• Patient Sex: Male